Spectraforce Technologies Inc
Bridgewater, New Jersey
Job title: CMC Regulatory Technical Writer II Location: Bridgewater, NJ, Hybrid Duration: 1 year SHIFT SCHEDULE 1st shift, 9-5 EST Mon-Fri Pay Rate starts: $47/ HOUR HM Notes: Hybrid - onsite Tuesday & Thursday - This can change at any time. 5 years experience with scientific background (BA/BS, MS or PhD) Must have experience with CTD (Common Technical Document) modules. Will complete regulatory submissions, compliance, and amendments. Expert in Microsoft Office (Word, Excel, PowerPoint) VEEVA experience is a plus Description: The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports. He/she coordinates directly with key stakeholders within industrial network, and with external partners (contract manufacturing organizations (CMOs), and alliance partners). Key Responsibilities: The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings). He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners. He/She identifies potential regulatory risks/challenges while ensuring Regulatory compliance. He/she authors autonomously the CMC sections of dossiers using templates and source documentation in accordance with Common Technical Document (CTD) guidances and company standards. He/She ensures delivery of sections in a timely manner. He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she performs life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements. He/She maintains an up to date knowledge of ways of working and SOPs and develops a comprehensive understanding of global CMC regulations and guidelines to enhance probability of regulatory success and regulatory compliance. He/She also authors other types of regulatory documents such as white papers, position papers, and briefing book. In parallel, the technical writer could help support non regulatory writing projects such as SOP and technical documents throughout the department.
04/20/2024
Full time
Job title: CMC Regulatory Technical Writer II Location: Bridgewater, NJ, Hybrid Duration: 1 year SHIFT SCHEDULE 1st shift, 9-5 EST Mon-Fri Pay Rate starts: $47/ HOUR HM Notes: Hybrid - onsite Tuesday & Thursday - This can change at any time. 5 years experience with scientific background (BA/BS, MS or PhD) Must have experience with CTD (Common Technical Document) modules. Will complete regulatory submissions, compliance, and amendments. Expert in Microsoft Office (Word, Excel, PowerPoint) VEEVA experience is a plus Description: The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports. He/she coordinates directly with key stakeholders within industrial network, and with external partners (contract manufacturing organizations (CMOs), and alliance partners). Key Responsibilities: The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings). He/she defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners. He/She identifies potential regulatory risks/challenges while ensuring Regulatory compliance. He/she authors autonomously the CMC sections of dossiers using templates and source documentation in accordance with Common Technical Document (CTD) guidances and company standards. He/She ensures delivery of sections in a timely manner. He/she manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she performs life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements. He/She maintains an up to date knowledge of ways of working and SOPs and develops a comprehensive understanding of global CMC regulations and guidelines to enhance probability of regulatory success and regulatory compliance. He/She also authors other types of regulatory documents such as white papers, position papers, and briefing book. In parallel, the technical writer could help support non regulatory writing projects such as SOP and technical documents throughout the department.
Summary This job is responsible for the project management of a new medical device as part of bigger development program. The role covers typical tasks and responsibilities of project management like planning, monitoring and reporting. Primary Responsibilities Managing of large-scale projects for product development (NPI) Creation and monitoring of project plans incl. milestone plan, COGS, project costs and NREs Reporting project status updates as well as project phase transitions to the executive management Identification and mitigation of project risks Guiding the project team through the individual development phases Alignment of shared resources within R&D Coordination of cooperation with the departments: Purchasing/ Service/ Production/ QM/ Manufacturing Engineering/ Regulatory Affairs/ PM and with customers as well as external Service Providers Initiating the procurement of materials for sample and prototype builds Initiation, coordination and maintenance of technical product documentation up to the product launch Ensure timely delivery of mandatory documents for each project phase Ensure fulfillment of customer expectations & customer satisfaction Escalation of critical project parameters to the program manager and superiors Ensure internal & external communication flow Internal alignment on customer communication strategy General Tasks Implementation of the departmental and product group strategy Coordination with other project managers on processes, interfaces and cross-sectional tasks Active participation in the innovation process & continuous improvement Strict compliance with the quality, occupational safety and environmental regulations. Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist. Required Experience, Education, Skills, Training and Competencies Min. of 3 years' experience in project management Proven track record of completed projects (with minimum budget of more than $0.3Mio) Experienced with classical project management as well as agile project management Experienced with common project management tools (e.g. MS Project, MS Azure or similar) Good knowledge of Microsoft Office tools, SharePoint Official project management certification desired (such as PMP, IPMA or Prince2) Positive attitude and intercultural sensitivity Self-motivated working style, always pushing the boundaries Attention to detail and systematic way of working Cross-functional 360deg view Quality-conscious, trustworthy and reliable Analytical, structured and systematic way of working Goal-oriented communication skills Team-oriented leadership Presentation skills (right content for right audience) Travel Requirements Willingness to travel within US and globally (Germany, Czech Republic) periodically
04/20/2024
Full time
Summary This job is responsible for the project management of a new medical device as part of bigger development program. The role covers typical tasks and responsibilities of project management like planning, monitoring and reporting. Primary Responsibilities Managing of large-scale projects for product development (NPI) Creation and monitoring of project plans incl. milestone plan, COGS, project costs and NREs Reporting project status updates as well as project phase transitions to the executive management Identification and mitigation of project risks Guiding the project team through the individual development phases Alignment of shared resources within R&D Coordination of cooperation with the departments: Purchasing/ Service/ Production/ QM/ Manufacturing Engineering/ Regulatory Affairs/ PM and with customers as well as external Service Providers Initiating the procurement of materials for sample and prototype builds Initiation, coordination and maintenance of technical product documentation up to the product launch Ensure timely delivery of mandatory documents for each project phase Ensure fulfillment of customer expectations & customer satisfaction Escalation of critical project parameters to the program manager and superiors Ensure internal & external communication flow Internal alignment on customer communication strategy General Tasks Implementation of the departmental and product group strategy Coordination with other project managers on processes, interfaces and cross-sectional tasks Active participation in the innovation process & continuous improvement Strict compliance with the quality, occupational safety and environmental regulations. Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist. Required Experience, Education, Skills, Training and Competencies Min. of 3 years' experience in project management Proven track record of completed projects (with minimum budget of more than $0.3Mio) Experienced with classical project management as well as agile project management Experienced with common project management tools (e.g. MS Project, MS Azure or similar) Good knowledge of Microsoft Office tools, SharePoint Official project management certification desired (such as PMP, IPMA or Prince2) Positive attitude and intercultural sensitivity Self-motivated working style, always pushing the boundaries Attention to detail and systematic way of working Cross-functional 360deg view Quality-conscious, trustworthy and reliable Analytical, structured and systematic way of working Goal-oriented communication skills Team-oriented leadership Presentation skills (right content for right audience) Travel Requirements Willingness to travel within US and globally (Germany, Czech Republic) periodically
Senior Manager Regulatory Affairs - Remote - Permanent Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position. This role is integral to the ongoing development, registration, and life-cycle management of our product candidates. Primary Responsibilities: The successful candidate will be responsible for supporting regulatory strategy, systems, processes, submissions, and health authority interactions. This role requires close collaboration with cross-functional team members within the company. Skills & Requirements: In-depth knowledge and high level of technical competence of regulatory systems (e.g., Veeva RIM and StartingPoint templates). Strong communication and collaboration skills. Experience in regulatory affairs within the pharmaceutical/biotechnology industry. The Senior Manager will: Support the implementation of the regional regulatory strategy and regulatory submission plans in line with business objectives. Facilitate tactical implementation at the regional level and contribute to effective communications with regional and global teams on product activities and issues. Participate in the preparation for meetings with regional regulatory agencies. Support communications with FDA in support of submissions. Prepare, review, and provide input on documents for submission to regional regulatory agencies. Collaborate with regulatory team members and functional subject matter experts to build and maintain the content plan for INDs, NDAs, etc. to ensure timely delivery of submission components. Maintain current IND, ODD, and NDA submissions by ensuring timely and appropriate submission of required information within eCTD sequence as well as maintaining logs. Contribute to the management of product lifecycle submissions (e.g., DSURs, IBs). If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) or . Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.
04/18/2024
Full time
Senior Manager Regulatory Affairs - Remote - Permanent Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position. This role is integral to the ongoing development, registration, and life-cycle management of our product candidates. Primary Responsibilities: The successful candidate will be responsible for supporting regulatory strategy, systems, processes, submissions, and health authority interactions. This role requires close collaboration with cross-functional team members within the company. Skills & Requirements: In-depth knowledge and high level of technical competence of regulatory systems (e.g., Veeva RIM and StartingPoint templates). Strong communication and collaboration skills. Experience in regulatory affairs within the pharmaceutical/biotechnology industry. The Senior Manager will: Support the implementation of the regional regulatory strategy and regulatory submission plans in line with business objectives. Facilitate tactical implementation at the regional level and contribute to effective communications with regional and global teams on product activities and issues. Participate in the preparation for meetings with regional regulatory agencies. Support communications with FDA in support of submissions. Prepare, review, and provide input on documents for submission to regional regulatory agencies. Collaborate with regulatory team members and functional subject matter experts to build and maintain the content plan for INDs, NDAs, etc. to ensure timely delivery of submission components. Maintain current IND, ODD, and NDA submissions by ensuring timely and appropriate submission of required information within eCTD sequence as well as maintaining logs. Contribute to the management of product lifecycle submissions (e.g., DSURs, IBs). If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) or . Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.
**Regulatory Affairs Quality Assurance Specialist** What's next for you? This great job. Kelly is looking for a dynamic **Regulatory Affairs / Quality Assurance Specialist** for our top biomedical client in Redmond, WA. The ideal candidate will have 2+ years' experience in a Quality Assurance role in a manufacturing environment with strong experience with NC's and CAPA's. This is a one-year contract role with possibility of extension. Hybrid, on-site, role. All candidates must be local to Redmond, WA. *** MUST BE ABLE TO WORK AS AN EMPLOYEE (ON W-2 BASIS) *** NO C2C, 1099, etc. *** + Shift: 8:00am to 5:00pm + Location: *HYBRID, remote/on-site. All candidate must be local to Redmond, WA. + Pay: $57.00 - 71.00/hour DOE & EDU **In this role you will:** + Conduct, write, and own CAPA investigations to determine the probable and verified root causes for nonconformities/out-of-specification events. + Ensure compliance to CAPA processes and procedures. + Support and implementation of changes related to projects in the product lifecycle system and quality management system. + Co-ordinates, prepares, and routes document packages for submissions. Liaise with relevant functional groups to gather all necessary changes and information. + Reviews and verifies document records to ensure the documentation complies with regulations and internal quality control practices. + May interact with regulatory agencies. + Works on problems of complex scope where data analysis requires evaluation of specific factors. + Utilizes independent judgment within broad parameters to determine an appropriate solution. May determine methods and procedures on new projects and may provide guidance to other lower-level staff. + This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. **Required:** + Requires a bachelor's degree. + Must be an expert with Microsoft Office Tools including Outlook, Word, Excel, SharePoint, and Teams + Must have previous experience in a regulated environment and working in a quality system and ISO compliance + Must have previous experience with document/procedure writing, updating, and management in a regulated environment. + Must have previous experience with NC's and CAPA's. + Support of RAQA projects including NC's, CAPA's, and process/document updates. **Why Kelly?** As a Kelly employee, you'll have access to world-class perks, including: + Kelly-sponsored Affordable Care Act health care coverage available to eligible employees + *Group insurance options + Service bonus plan + Holiday pay plan + Weekly electronic pay options + Online training campus that provides more than 3,000 free courses to help improve and develop skills + Exclusive online employee community + Employee assistance program available at no cost + Corporate discounts + Transportation Spending Accounts *Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services. **Apply Today!** *Important information: This position is recruited by a remote, national, Kelly office, NOT your local Kelly branch. Applicant must have a legal right to work in the US without sponsorship or VISA transfer for this position. There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs **Why Kelly** **®** **?** Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job. **About Kelly** **®** At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
02/13/2022
Full time
**Regulatory Affairs Quality Assurance Specialist** What's next for you? This great job. Kelly is looking for a dynamic **Regulatory Affairs / Quality Assurance Specialist** for our top biomedical client in Redmond, WA. The ideal candidate will have 2+ years' experience in a Quality Assurance role in a manufacturing environment with strong experience with NC's and CAPA's. This is a one-year contract role with possibility of extension. Hybrid, on-site, role. All candidates must be local to Redmond, WA. *** MUST BE ABLE TO WORK AS AN EMPLOYEE (ON W-2 BASIS) *** NO C2C, 1099, etc. *** + Shift: 8:00am to 5:00pm + Location: *HYBRID, remote/on-site. All candidate must be local to Redmond, WA. + Pay: $57.00 - 71.00/hour DOE & EDU **In this role you will:** + Conduct, write, and own CAPA investigations to determine the probable and verified root causes for nonconformities/out-of-specification events. + Ensure compliance to CAPA processes and procedures. + Support and implementation of changes related to projects in the product lifecycle system and quality management system. + Co-ordinates, prepares, and routes document packages for submissions. Liaise with relevant functional groups to gather all necessary changes and information. + Reviews and verifies document records to ensure the documentation complies with regulations and internal quality control practices. + May interact with regulatory agencies. + Works on problems of complex scope where data analysis requires evaluation of specific factors. + Utilizes independent judgment within broad parameters to determine an appropriate solution. May determine methods and procedures on new projects and may provide guidance to other lower-level staff. + This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. **Required:** + Requires a bachelor's degree. + Must be an expert with Microsoft Office Tools including Outlook, Word, Excel, SharePoint, and Teams + Must have previous experience in a regulated environment and working in a quality system and ISO compliance + Must have previous experience with document/procedure writing, updating, and management in a regulated environment. + Must have previous experience with NC's and CAPA's. + Support of RAQA projects including NC's, CAPA's, and process/document updates. **Why Kelly?** As a Kelly employee, you'll have access to world-class perks, including: + Kelly-sponsored Affordable Care Act health care coverage available to eligible employees + *Group insurance options + Service bonus plan + Holiday pay plan + Weekly electronic pay options + Online training campus that provides more than 3,000 free courses to help improve and develop skills + Exclusive online employee community + Employee assistance program available at no cost + Corporate discounts + Transportation Spending Accounts *Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services. **Apply Today!** *Important information: This position is recruited by a remote, national, Kelly office, NOT your local Kelly branch. Applicant must have a legal right to work in the US without sponsorship or VISA transfer for this position. There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs **Why Kelly** **®** **?** Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job. **About Kelly** **®** At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
09/26/2021
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
09/25/2021
Summary Alameda Health System is hiring!The Administrative Director of Public Affairs & Community Engagement r epresents AHS in federal, state and local legislative issues; reviews legislation and regulations important to AHS's interest; establishes relationships with key federal, state, county and local elected and appointed officials, community, employer and physician based organizations; develops AHS's position on legislative issues; informs internal departments of legislative changes and activities; serves as an AHS representative in meetings and liaisons between AHS and various community meetings and committees; oversees and supervises staff of the Public Affairs and Community Engagement Unit; works with senior management and other system leaders to develop, implement and manage a community affairs/public affairs plan that builds trust and support for the system among opinion leaders and elected officials; develops community relations programs for the system and each entity to achieve the system's marketing objectives; works directly and regularly with the Executive Team, leadership, medical staff and community members; continuously interacts with senior management, chairs, chiefs, medical directors and other physicians and managers. The position reports to the Chief Administrative Officer (CAO), Population Health. DUTIES & ESSENTIAL JOB FUNCTIONS: NOTE: The following are the duties performed by employees in this classification, however, employees may perform other related duties at an equivalent level. Not all duties listed are necessarily performed by each individual in the classification. Advises entity leadership (campus Administrators, entity leaders/associate administrators) and other appropriate staff (e.g., marketing representatives) of community outreach opportunities within the entity service area. Supports community relations specialist and on-site personnel in facilitating hospital community relations meetings and initiating and implementing community relations activities that support the entities' goals and objectives; serves as a liaison to strategic community organizations. Develops strategies and recommends/plans politically responsive activities for AHS; works with the CAO, Population Health and the Executive Team to develop AHS's position on important legislative and regulatory matters; coordinates meetings, events, and communication with local government officials, state legislators, and members of Congress, when necessary. Directs, coordinates and develops strategic and tactical plans and policies for consideration by the CAO Population Health including confidential and sensitive topics concerning collective bargaining agreement terms, conditions and proposals by AHS to bargaining unit entities in collaboration with and consultation from the Chief Human Resources Officer. Informs the Executive Team and internal departments of current legislation; works with programs to obtain background information on legislative issues; presents updates as appropriate and necessary; Keeps AHS leadership updated on public affairs and community affairs activities. Acts as consultant/liaison to AHS campus administrators in supporting day-to-day entity public affairs activities that meet entity and corporate objectives; supports the implementation of entity and system-wide strategic plans and books of business. Manages system effort to research, develop, implement and evaluate strategies for proactive community outreach campaigns that will improve visibility and support for each entity in its respective community. Plans and establishes, with AHS marketing, communications, business development and project management staff an active leadership role for AHS in government and industry organizations and other appropriate segments of the community; contributes to AHS's visibility and influence within these constituencies; coordinates efforts with marketing and business development leadership to integrate marketing and communications goals designed to increase number of individuals selecting AHS as their health care provider. Establishes and maintains good and active working relationships with key personnel in government agencies, key elected officials, the California Legislature, executive branch, and regulatory agencies in the federal, state and county, and with representatives of other organizations interested in health care and health policy, specifically in areas that could potentially impact AHS. Represents AHS in appropriate health industry, allied and related business, and community organizations. Actively participates on local committees and at functions as appropriate. Intervenes at city, county, state and federal levels to gain timely support for AHS's interests. Monitoring legislation and executive meetings and reports; reviews and summarizes legislation important to AHS programs; coordinates with the CAO, appropriate involvement in certain issues; lobbies legislators to promote the organization's position on certain legislation, as needed. Stays abreast of legislative activity with the potential to impact system; makes recommendations for appropriate corporate response and, when appropriate, actively influences legislative and community outcomes. Supports AHS leadership in planning and evaluating entity-based county, state and federal community affairs/public affairs programs. Works with AHS public relations leadership to develop communication strategies regarding community relations activities, ensuring a consistent public image and integrated messages for the system; participates in AHS communications rotational weekend "on-call" media duties; serves as media spokesperson as assigned. Writing for internal publications: Manages the design, content development and distribution of the electronic legislative update. Develops and supplies stories for system internal and external publications, including employee publications. Researches, writes and/or ensures regular reports, bulletins, articles, and other necessary legislative reports (including final reports from legislative sessions); researches key issues and recommends an AHS position; researches and responds to inquiries from elected officials. Assists with writing for community relations or corporate projects, when necessary; provides ideas for and occasionally writes story ideas or copy for system's publications, including employee publications. Performs other duties as assigned. Qualifications: Any combination of education and experience that would likely provide the required knowledge, skills and abilities as well as possession of any required licenses or certifications is qualifying. Required Education: Bachelor's degree in political science, history, public relations, journalism, English or communications or a field related to health care of business from an accredited college or university. Preferred Education: Master's degree in Public Health, Public Administration, Hospital Administration, Business Administration or Political Science. Required Experience: Three years in government health care advocacy at the federal, state or local level; five to seven years of public relations and governmental relations; Three years supervisory experience. Fairmont Hospital Corp Communications Marketing Full Time Day Management FTE: 1
With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! The Global Regulatory Affairs (GRA) Region North America, Therapeutic Area Lead (TA Lead) is a member of the GRA Region North America Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by: Leading and overseeing GRA Region North America regulatory teams for assigned therapeutic area. Leading the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio. Driving and executing comprehensive, commercially and globally aligned regulatory activities/strategies within the region for CSL Behring's product portfolio throughout development and after commercialization. Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. Contributing to Regional regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within GRA Region North America and assesses these changes for impact to the business and CSL Behring's product portfolio. May represent CSL Behring on Industry forums. Collaborating and aligning with GRA functional TA & Site Leads, as appropriate, including exchanging information on relevant topics. Act as the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s). In limited situations, may act as regional representative for specific development projects to Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy. Reporting Relationships: Role that this position reports to: Head, GRA Region, North America Roles that may report to this position: Regional Senior Regulatory Manager, Region, North America Regional Regulatory Manager, Region North America Regional Regulatory Scientist, Region North America Regional Regulatory Specialist, Region North America Main Responsibilities and Accountabilities: 1. Works closely with the Head, GRA Region to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the regional regulatory perspective to stakeholders, regardless of level, and supports effective GRAST teams for assigned therapeutic area. Contributes to GRA Region Leadership Team (GRA RLT). 2. Accountable for CSL Behring's relationship with respective health authorities within the region. Ensures high quality working relationships are established and/or maintained with regional health authorities and negotiates with these authorities to achieve positive outcomes for CSL Behring. Leverages global GRA functions to support this objective, as appropriate. 3. Provides a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influences the regional regulatory strategy in alignment with the global regulatory strategy. 4. Drives and executes comprehensive, commercially and globally aligned regulatory activities within the region for assigned therapeutic area throughout development including timely and successful registration of new products and maintenance of existing products. Ensures understanding and regional alignment of regulatory activities amongst the GRA Region staff. 5. Empowers and advises the members of GRA Region Therapeutic Area to ensure that the project portfolio objectives are met within the region. Additionally, provide strategic and tactical regulatory leadership and guidance for Regional Regulatory Senior Managers/Managers, Regulatory Scientists/Specialists, as appropriate. 6. When acting as a regional representative to GRAST, provide regional regulatory perspective, advocate and drive the 'one GRA' perspective with team stakeholders. 7. Enables growth and professional development of the GRA Region team members, including succession planning for critical roles with GRALT. Ensures all team members have been trained on their role. 8. Responsible to interact with therapeutic area / site leads for all of GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate. 9. Responsible to interact with key internal stakeholders, such as Regional Commercial Operations and affiliate regulatory affairs, on a regular basis to ensure delivery of successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. 10. Implements and maintains global regulatory processes and operations for GRA Region. Implement/utilize electronic systems in line with GRA Operational Excellence. Ensures all team members have been trained. 11. Represents CSL Behring on industry forums to drive changes in the regulatory environment, as appropriate. Fosters regulatory intelligence for data generated within CSL Behring, specifically in GRA Region North America Leadership Manage the Regional regulatory activities in alignment with the Global Regulatory Affairs activities. Driving Performance Sets clear expectations/objectives aligned with CSL Company Objectives Provides an appropriate balance of direction and support to manage the performance of direct reports Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level Evaluates performance, gives feedback and recognizes results Ensures operational efficiencies that contribute to our bottom line Building Productive Teams Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions Builds a productive, engaging team culture and climate based on trust, respect, and mutual support Clarifies team roles, goals, mission, and ground rules Builds networks with other CSL teams to support business objectives ("One CSL") When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams Developing People On-boards new hires Recognizes and develops the potential of direct reports Holds professional development and career discussions with direct reports Provides opportunities for team members to learn and grow Develops self Creating the Future Serves as a role model for CSL's Values Lives CSL's mission, vision, and strategy and develops action plans to drive strategy execution Is dedicated to fulfilling the needs of internal and external customers and stakeholders Challenges the status quo; fosters innovation and continuous improvement Applies business acumen skills to help grow the business Position Qualifications and Experience Requirements: Education A bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous. Experience At minimum 10 years' experience in the pharmaceutical industry, preferably in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree. At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience. Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities. Experience in leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes. Experience working with external stakeholder bodies, e.g. trade associations is advantageous. Demonstrated experience in working in a complex and matrix environment with multiple stakeholders is required. Competencies ..... click apply for full job details
09/12/2021
Full time
With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team! The Global Regulatory Affairs (GRA) Region North America, Therapeutic Area Lead (TA Lead) is a member of the GRA Region North America Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by: Leading and overseeing GRA Region North America regulatory teams for assigned therapeutic area. Leading the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio. Driving and executing comprehensive, commercially and globally aligned regulatory activities/strategies within the region for CSL Behring's product portfolio throughout development and after commercialization. Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. Contributing to Regional regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within GRA Region North America and assesses these changes for impact to the business and CSL Behring's product portfolio. May represent CSL Behring on Industry forums. Collaborating and aligning with GRA functional TA & Site Leads, as appropriate, including exchanging information on relevant topics. Act as the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s). In limited situations, may act as regional representative for specific development projects to Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy. Reporting Relationships: Role that this position reports to: Head, GRA Region, North America Roles that may report to this position: Regional Senior Regulatory Manager, Region, North America Regional Regulatory Manager, Region North America Regional Regulatory Scientist, Region North America Regional Regulatory Specialist, Region North America Main Responsibilities and Accountabilities: 1. Works closely with the Head, GRA Region to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the regional regulatory perspective to stakeholders, regardless of level, and supports effective GRAST teams for assigned therapeutic area. Contributes to GRA Region Leadership Team (GRA RLT). 2. Accountable for CSL Behring's relationship with respective health authorities within the region. Ensures high quality working relationships are established and/or maintained with regional health authorities and negotiates with these authorities to achieve positive outcomes for CSL Behring. Leverages global GRA functions to support this objective, as appropriate. 3. Provides a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influences the regional regulatory strategy in alignment with the global regulatory strategy. 4. Drives and executes comprehensive, commercially and globally aligned regulatory activities within the region for assigned therapeutic area throughout development including timely and successful registration of new products and maintenance of existing products. Ensures understanding and regional alignment of regulatory activities amongst the GRA Region staff. 5. Empowers and advises the members of GRA Region Therapeutic Area to ensure that the project portfolio objectives are met within the region. Additionally, provide strategic and tactical regulatory leadership and guidance for Regional Regulatory Senior Managers/Managers, Regulatory Scientists/Specialists, as appropriate. 6. When acting as a regional representative to GRAST, provide regional regulatory perspective, advocate and drive the 'one GRA' perspective with team stakeholders. 7. Enables growth and professional development of the GRA Region team members, including succession planning for critical roles with GRALT. Ensures all team members have been trained on their role. 8. Responsible to interact with therapeutic area / site leads for all of GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate. 9. Responsible to interact with key internal stakeholders, such as Regional Commercial Operations and affiliate regulatory affairs, on a regular basis to ensure delivery of successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions. 10. Implements and maintains global regulatory processes and operations for GRA Region. Implement/utilize electronic systems in line with GRA Operational Excellence. Ensures all team members have been trained. 11. Represents CSL Behring on industry forums to drive changes in the regulatory environment, as appropriate. Fosters regulatory intelligence for data generated within CSL Behring, specifically in GRA Region North America Leadership Manage the Regional regulatory activities in alignment with the Global Regulatory Affairs activities. Driving Performance Sets clear expectations/objectives aligned with CSL Company Objectives Provides an appropriate balance of direction and support to manage the performance of direct reports Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level Evaluates performance, gives feedback and recognizes results Ensures operational efficiencies that contribute to our bottom line Building Productive Teams Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions Builds a productive, engaging team culture and climate based on trust, respect, and mutual support Clarifies team roles, goals, mission, and ground rules Builds networks with other CSL teams to support business objectives ("One CSL") When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams Developing People On-boards new hires Recognizes and develops the potential of direct reports Holds professional development and career discussions with direct reports Provides opportunities for team members to learn and grow Develops self Creating the Future Serves as a role model for CSL's Values Lives CSL's mission, vision, and strategy and develops action plans to drive strategy execution Is dedicated to fulfilling the needs of internal and external customers and stakeholders Challenges the status quo; fosters innovation and continuous improvement Applies business acumen skills to help grow the business Position Qualifications and Experience Requirements: Education A bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous. Experience At minimum 10 years' experience in the pharmaceutical industry, preferably in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree. At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience. Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities. Experience in leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes. Experience working with external stakeholder bodies, e.g. trade associations is advantageous. Demonstrated experience in working in a complex and matrix environment with multiple stakeholders is required. Competencies ..... click apply for full job details
Our client is the largest global provider of naturally sourced colors for the food, beverage, dietary supplements and pet food industry! They have drawn on the power of nature's true colors and championed that natural is best. We have been retained to find a Senior Regulatory Specialist! This position works under limited direction and is primarily responsible for responding to internal and external inquiries related to the company's products and the regulations governing them. Summary: Researches and prepares timely and accurate responses to customer inquiries regarding the domestic and international regulatory status of products, specification, allergen and certifications. Assists in the operation of systems and procedures to ensure timely and accurate data collection, maintenance and delivery of consistent regulatory information throughout the organization. Communicates with government agencies (FDA, CBP, USDA, CFIA) on a regular basis regarding regulatory compliance of our products and processes. Monitors regulatory changes affecting company products and communicates to appropriate inter-company stakeholders. Supports the business unit division regarding securing registrations, certifications and regulatory dossiers for internal use and submission to government and 3rd party entities. Supports the sales team with assisting customers on ingredient regulation and labeling requirements. Takes a leadership role in external affairs under the direction of the Regulatory Affairs Manager. Support to requests from 3rd party certifying bodies (OMRI, etc.). Provides leadership, support, training and guidance to Regulatory Affairs Specialists where appropriate. Job Requirements: Requirements: Bachelor's Degree in a scientific or technical area with five plus years of regulatory experience. Possess a thorough understanding of North American food law and regulations. Must be a self-starter and be able to multi-task. Possess an inquisitive mind and the ability to redirect or reword inquiries to various agencies to attain the required information. Ability to assess broad impact of decisions, and where necessary conduct formal and informal impact assessments in collaboration with the Business Units and with the guidance of Regulatory Affairs Manager. Ability to use ERP system (i.e. SAP) to access raw material information, formulas and/or processes. Possess a working knowledge in Microsoft Office programs.
09/11/2021
Full time
Our client is the largest global provider of naturally sourced colors for the food, beverage, dietary supplements and pet food industry! They have drawn on the power of nature's true colors and championed that natural is best. We have been retained to find a Senior Regulatory Specialist! This position works under limited direction and is primarily responsible for responding to internal and external inquiries related to the company's products and the regulations governing them. Summary: Researches and prepares timely and accurate responses to customer inquiries regarding the domestic and international regulatory status of products, specification, allergen and certifications. Assists in the operation of systems and procedures to ensure timely and accurate data collection, maintenance and delivery of consistent regulatory information throughout the organization. Communicates with government agencies (FDA, CBP, USDA, CFIA) on a regular basis regarding regulatory compliance of our products and processes. Monitors regulatory changes affecting company products and communicates to appropriate inter-company stakeholders. Supports the business unit division regarding securing registrations, certifications and regulatory dossiers for internal use and submission to government and 3rd party entities. Supports the sales team with assisting customers on ingredient regulation and labeling requirements. Takes a leadership role in external affairs under the direction of the Regulatory Affairs Manager. Support to requests from 3rd party certifying bodies (OMRI, etc.). Provides leadership, support, training and guidance to Regulatory Affairs Specialists where appropriate. Job Requirements: Requirements: Bachelor's Degree in a scientific or technical area with five plus years of regulatory experience. Possess a thorough understanding of North American food law and regulations. Must be a self-starter and be able to multi-task. Possess an inquisitive mind and the ability to redirect or reword inquiries to various agencies to attain the required information. Ability to assess broad impact of decisions, and where necessary conduct formal and informal impact assessments in collaboration with the Business Units and with the guidance of Regulatory Affairs Manager. Ability to use ERP system (i.e. SAP) to access raw material information, formulas and/or processes. Possess a working knowledge in Microsoft Office programs.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter. The PV Alliance Management (PVAM) Specialist plays a key role in the PVAM Team, facilitating across functional teams, building relationships, and supporting the delivery of high quality PV Agreements to ensure timely and accurate collection, safety review, processing and reporting of adverse event data in compliance with applicable global regulations and Jazz Pharmaceuticals standard operating procedures and guidelines. To this end, the PVAM Specialist guides and facilitates effective working relationships within R&D Global Pharmacovigilance and Labeling, and cross-functionally with strategic departments within the company and its affiliates/subsidiaries to foster smooth, accurate, and timely flow of activities related to PV Agreements (PVA)s as well as effective contractual relationships with PV Service Providers. The PVAM Specialist is versed on PVAs, Safety Reporting Plans (SRPs), PV Service Provider Agreements, and acts as key contact person for internal and external customers, managing these alliances directly and working with the PVAM Team as well as in partnership with cross-functional staff. Working with the PVAM Manager, the Specialist may negotiate and maintain Agreements, including maintenance and reporting of KPIs/SLAs and participate in vendor governance. The Specialist will be responsible for coordinating PV activities related to Global Expansion in Canada and US. The PVAM Specialist may assist in special projects as assigned by the Pharmacovigilance (PV) department management. The PVAM Specialists have a breadth of responsibilities which are prioritized within the PVAM Team, and may be assigned to: Business Development & Opportunities Global PV Vendor Services Regional PV Vendor Services PVAM Specialist responsibilities may include PV alliance activities such as, but not limited to: Serve as the liaison between Global Pharmacovigilance and cross functional organizations, acting as a Pharmacovigilance ambassador and domain expert as well as increasing awareness within Global Pharmacovigilance of cross-functional customer/stakeholder needs and dependencies, including PV Service providers. Support implementation for new partnerships and maintenance/change Support establishment and maintenance of PVAs/SRPs/SPOPs/WOs associated with new business initiatives and opportunities. Interact with business process owners for additional information to address questions in establishing a PVA/SRP/SPOP/WO. Coordinate the PVA/SRP review by the safety review team, summarize agreement comments, and participate in the negotiation of the agreement. Contribute to resolving conflicts at team level or higher and facilitate decision making within the team. Escalate issues utilizing governance models and standard communication plans. Coordinate implementation of Safety Reporting plans for programs with the potential to generate safety information. Coordinate PV activities associated with in/out-licensing and marketing authorizations/withdrawals in Canada and United States. Collaborate with the cross-functional groups that have responsibility for activities that may generate adverse events or safety information such as (not limited to) Business Alliance/Development, Commercial, Medical Affairs. Support collection of information required to update designated sections of the PSMF. Organize and moderate meetings and author minutes/discussion summaries. Solicit items for and set agendas. Send out draft minutes/summaries for comments to both internal Global Pharmacovigilance and external PV Service Providers, and distribute final summaries to all participants, as well as senior PVAM staff. Follow up with meeting participants on the resolution of action items from meetings. Maintain and organize internal PVAM files (Agreements, supporting documents, meeting minutes). Participate in maintaining PVAM Jazz Portal and Mailbox. Conduct ad hoc/special projects and analyses for PVAM management. PVAM Specialist Essential Functions Adheres to company templates and GxP guidelines for documentation and communications Ensures compliance with corporate and departmental policies, standard operating procedures, and timely completion of all assigned training Other duties as required to support PVAM team Participate in the development and maintenance of PVAM activity workflow processes, department policies, work instructions, standard operating procedures and training material when new and/or updated processes are introduced May serve as an individual contributor or a project manager for functional projects or workflows. May mentor other team members Participation in Inspections and Audits as identified, as well as active role in maintaining a business as usual inspection ready state of operating Takes responsibility for personal development and continuous improvement including keeping up to date with pharmacovigilance practices, legislation and guidelines. Work collaboratively with cross-functional teams to evaluate the performance, identify bottlenecks, minimize regulatory risks and recognize patterns of inefficiencies in current operational processes Collaborate effectively with Quality Assurance, Legal, and Project Management. Minimum Requirements BS/BA degree in health related or biological science related field 3 plus years of pharmaceutical drug safety/pharmacovigilance operations experience In depth knowledge of pharmacovigilance activities and processes, with a preference for experience in more than one PV functional area Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS. Experience interacting with service providers or external business partners Excellent teamwork and interpersonal skills are required with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships Excellent oral and written communication skills, demonstrating professional maturity, confidence and competence Ability to work effectively within a matrix organization to achieve desired outcomes Track record of effective decision-making; makes good business decisions and analyses problems from multiple perspectives Ability to work across cultures, including in a virtual environment Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook) Team Building, Motivating and Influencing Others without authority Promoting Innovation and Process Improvement Maintaining activities Negotiation skills Strong analytical skills Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
09/11/2021
Full time
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter. The PV Alliance Management (PVAM) Specialist plays a key role in the PVAM Team, facilitating across functional teams, building relationships, and supporting the delivery of high quality PV Agreements to ensure timely and accurate collection, safety review, processing and reporting of adverse event data in compliance with applicable global regulations and Jazz Pharmaceuticals standard operating procedures and guidelines. To this end, the PVAM Specialist guides and facilitates effective working relationships within R&D Global Pharmacovigilance and Labeling, and cross-functionally with strategic departments within the company and its affiliates/subsidiaries to foster smooth, accurate, and timely flow of activities related to PV Agreements (PVA)s as well as effective contractual relationships with PV Service Providers. The PVAM Specialist is versed on PVAs, Safety Reporting Plans (SRPs), PV Service Provider Agreements, and acts as key contact person for internal and external customers, managing these alliances directly and working with the PVAM Team as well as in partnership with cross-functional staff. Working with the PVAM Manager, the Specialist may negotiate and maintain Agreements, including maintenance and reporting of KPIs/SLAs and participate in vendor governance. The Specialist will be responsible for coordinating PV activities related to Global Expansion in Canada and US. The PVAM Specialist may assist in special projects as assigned by the Pharmacovigilance (PV) department management. The PVAM Specialists have a breadth of responsibilities which are prioritized within the PVAM Team, and may be assigned to: Business Development & Opportunities Global PV Vendor Services Regional PV Vendor Services PVAM Specialist responsibilities may include PV alliance activities such as, but not limited to: Serve as the liaison between Global Pharmacovigilance and cross functional organizations, acting as a Pharmacovigilance ambassador and domain expert as well as increasing awareness within Global Pharmacovigilance of cross-functional customer/stakeholder needs and dependencies, including PV Service providers. Support implementation for new partnerships and maintenance/change Support establishment and maintenance of PVAs/SRPs/SPOPs/WOs associated with new business initiatives and opportunities. Interact with business process owners for additional information to address questions in establishing a PVA/SRP/SPOP/WO. Coordinate the PVA/SRP review by the safety review team, summarize agreement comments, and participate in the negotiation of the agreement. Contribute to resolving conflicts at team level or higher and facilitate decision making within the team. Escalate issues utilizing governance models and standard communication plans. Coordinate implementation of Safety Reporting plans for programs with the potential to generate safety information. Coordinate PV activities associated with in/out-licensing and marketing authorizations/withdrawals in Canada and United States. Collaborate with the cross-functional groups that have responsibility for activities that may generate adverse events or safety information such as (not limited to) Business Alliance/Development, Commercial, Medical Affairs. Support collection of information required to update designated sections of the PSMF. Organize and moderate meetings and author minutes/discussion summaries. Solicit items for and set agendas. Send out draft minutes/summaries for comments to both internal Global Pharmacovigilance and external PV Service Providers, and distribute final summaries to all participants, as well as senior PVAM staff. Follow up with meeting participants on the resolution of action items from meetings. Maintain and organize internal PVAM files (Agreements, supporting documents, meeting minutes). Participate in maintaining PVAM Jazz Portal and Mailbox. Conduct ad hoc/special projects and analyses for PVAM management. PVAM Specialist Essential Functions Adheres to company templates and GxP guidelines for documentation and communications Ensures compliance with corporate and departmental policies, standard operating procedures, and timely completion of all assigned training Other duties as required to support PVAM team Participate in the development and maintenance of PVAM activity workflow processes, department policies, work instructions, standard operating procedures and training material when new and/or updated processes are introduced May serve as an individual contributor or a project manager for functional projects or workflows. May mentor other team members Participation in Inspections and Audits as identified, as well as active role in maintaining a business as usual inspection ready state of operating Takes responsibility for personal development and continuous improvement including keeping up to date with pharmacovigilance practices, legislation and guidelines. Work collaboratively with cross-functional teams to evaluate the performance, identify bottlenecks, minimize regulatory risks and recognize patterns of inefficiencies in current operational processes Collaborate effectively with Quality Assurance, Legal, and Project Management. Minimum Requirements BS/BA degree in health related or biological science related field 3 plus years of pharmaceutical drug safety/pharmacovigilance operations experience In depth knowledge of pharmacovigilance activities and processes, with a preference for experience in more than one PV functional area Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS. Experience interacting with service providers or external business partners Excellent teamwork and interpersonal skills are required with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships Excellent oral and written communication skills, demonstrating professional maturity, confidence and competence Ability to work effectively within a matrix organization to achieve desired outcomes Track record of effective decision-making; makes good business decisions and analyses problems from multiple perspectives Ability to work across cultures, including in a virtual environment Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook) Team Building, Motivating and Influencing Others without authority Promoting Innovation and Process Improvement Maintaining activities Negotiation skills Strong analytical skills Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Introduction /> Is This The Role For You? We hire smart people with big hearts. People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role. If you're ready for a career that allows you to grow and develop into the professional you want to be - today and in the future….CryoLife is the place for you. Position Overview /> The Regulatory Affairs (RA) Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions, and obtaining and maintaining approval for products to markets worldwide. Additionally, the RA Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. The RA Specialist will work independently and manage their own regulatory projects. Responsibilities /> • Define the regulatory strategies and submission activities (510(k), IDE, PMA, EU/CE Technical Documentation Files, Canadian License, international registrations, including amendments, supplements, renewals, annual reports and responses to requests for additional information) for complex new product development activities and product maintenance for existing approved products. • Team with global partners and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with cross-functional teams and subject matter experts to maintain regulatory compliance and address questions from regulatory agencies. • Review significant product submissions with project stakeholders and negotiate submission issues with agency personnel. Ensure timely submission approvals and product market release. • Provide support to currently marketed products, including review of labeling, promotional material, product changes and documentation for changes. • Support regulatory compliance activities, including facility site registrations, audits, etc., as needed. • Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. • Provide feedback and on-going support to product development teams for regulatory issues and questions. • Ensure personal understanding of all quality policy/system items that are personally applicable. • Follow all work/quality procedures to ensure quality system compliance and high-quality work. • Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.) • Maintain and update regulatory processes and SOPs. Qualifications /> • Bachelor's degree and a minimum of 2 years of regulatory experience or an advanced degree with a minimum of 1 years of regulatory experience. • Experience with FDA Class II or III devices or experience with EU Class IIb or III devices. • Experience working with cross-functional teams. • Ability to comprehend principles of engineering, physiology, and medical device use. • Ability to effectively manage and prioritize numerous projects and responsibilities. • Strong analytical, technical writing, verbal/written communication, organizational, and time management skills. • Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects. Must be legally authorized to work in the United States Must be willing to submit to a pre-employment background check and drug screen Must be at least 18 years of age Preferred: • Experience with Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices or human tissue. Company Info /> Who We Are. CryoLife is one of the world's contemporary medical device companies providing preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. Since the Company's inception in 1984, it is estimated that its products and tissues have been implanted in about 900,000 patients worldwide. CryoLife technology and products bring restoration and hope to people all around the world. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of Atlanta. CryoLife is an Equal Opportunity/Affirmative Action employer. CryoLife is committed to the philosophy of equal opportunity employment. We do not discriminate against any employee or applicant. All qualified candidates will receive consideration for employment without regard to race, ethnicity, age, religion, sex, sexual orientation, national origin, citizenship, disability, veterans or other legally protected status. Reasonable Accommodations CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email or call . A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.
09/08/2021
Full time
Introduction /> Is This The Role For You? We hire smart people with big hearts. People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role. If you're ready for a career that allows you to grow and develop into the professional you want to be - today and in the future….CryoLife is the place for you. Position Overview /> The Regulatory Affairs (RA) Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions, and obtaining and maintaining approval for products to markets worldwide. Additionally, the RA Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. The RA Specialist will work independently and manage their own regulatory projects. Responsibilities /> • Define the regulatory strategies and submission activities (510(k), IDE, PMA, EU/CE Technical Documentation Files, Canadian License, international registrations, including amendments, supplements, renewals, annual reports and responses to requests for additional information) for complex new product development activities and product maintenance for existing approved products. • Team with global partners and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with cross-functional teams and subject matter experts to maintain regulatory compliance and address questions from regulatory agencies. • Review significant product submissions with project stakeholders and negotiate submission issues with agency personnel. Ensure timely submission approvals and product market release. • Provide support to currently marketed products, including review of labeling, promotional material, product changes and documentation for changes. • Support regulatory compliance activities, including facility site registrations, audits, etc., as needed. • Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. • Provide feedback and on-going support to product development teams for regulatory issues and questions. • Ensure personal understanding of all quality policy/system items that are personally applicable. • Follow all work/quality procedures to ensure quality system compliance and high-quality work. • Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk Management, etc.) • Maintain and update regulatory processes and SOPs. Qualifications /> • Bachelor's degree and a minimum of 2 years of regulatory experience or an advanced degree with a minimum of 1 years of regulatory experience. • Experience with FDA Class II or III devices or experience with EU Class IIb or III devices. • Experience working with cross-functional teams. • Ability to comprehend principles of engineering, physiology, and medical device use. • Ability to effectively manage and prioritize numerous projects and responsibilities. • Strong analytical, technical writing, verbal/written communication, organizational, and time management skills. • Must be flexible, able to adapt easily, and willing to take initiative and lead regulatory projects. Must be legally authorized to work in the United States Must be willing to submit to a pre-employment background check and drug screen Must be at least 18 years of age Preferred: • Experience with Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices or human tissue. Company Info /> Who We Are. CryoLife is one of the world's contemporary medical device companies providing preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. Since the Company's inception in 1984, it is estimated that its products and tissues have been implanted in about 900,000 patients worldwide. CryoLife technology and products bring restoration and hope to people all around the world. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of Atlanta. CryoLife is an Equal Opportunity/Affirmative Action employer. CryoLife is committed to the philosophy of equal opportunity employment. We do not discriminate against any employee or applicant. All qualified candidates will receive consideration for employment without regard to race, ethnicity, age, religion, sex, sexual orientation, national origin, citizenship, disability, veterans or other legally protected status. Reasonable Accommodations CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email or call . A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.
Our client is a biotechnology and regenerative medicine company that discovers, develops, and delivers innovative biotherapies. They have an immediate opening for a highly motivated person interested in joining their Liver Team in a fast-paced, team and results-oriented work environment. As the Regulatory Affairs Program Manager, you will implement regulatory and strategic business requirements into whole organ program requirements including but not limited to, advising on applicable testing, managing documentation needs and timelines, and support, preparation, and execution of regulatory submissions. This program management role will focus on support for the liver whole organ regenerative medicine program taking a bioengineered liver from pre-clinical to first-in-human trials and ultimately a biological license application. The novelty of this regenerative medicine product will require flexibility, extrapolation, and a willingness to come up with and consider a broad spectrum of novel regulatory needs and solutions. You will need to leverage your existing biologics knowledge but not be confined to box-checking as we move into areas not directly contemplated by regulatory authorities. In this role, you will have primary program management responsibility for the whole bioengineered liver program, a completely novel human cell, tissue, and cellular and tissue-based product. You will need to collaborate cross-functionally to facilitate and meet all regulatory and business objectives within stated timelines. This role is a once-in-a-lifetime opportunity for the right regulatory professional to help hundreds of thousands of patients, by bringing a paradigm-changing, history-making human cell, tissue, and cellular and tissue-based therapeutic to market. What Youll Be Doing: Appropriately implement FDA regulations to ensure the compliant development and approval of biologic products. Develop, modify, and execute regulatory policies that affect immediate and future operations. Defining and executing tactical implementation plans working directly with the development team. Develop strategies and produce detailed regulatory plans and submissions including Pre-IND, IND, BLA and special designation requests. Effectively communicate regulatory needs to cross functional teams supporting biologic development and regulatory submission. Coordinate testing required to support regulatory approvals. Facilitate, prepare, and participate in meetings with regulatory agencies. Work closely with Clinical Specialist Medical Writers to direct writing needs including content and format. What You Have: Bachelors Degree (Masters or Ph.D. preferred) Minimum 8 years of biologic or pharma regulatory experience Minimum 5 years of project/people management experience Personal experience with successful regulatory submissions Proficient knowledge of FDA regulations, especially 21 CFR 1271 and 21 CFR 312
08/31/2021
Full time
Our client is a biotechnology and regenerative medicine company that discovers, develops, and delivers innovative biotherapies. They have an immediate opening for a highly motivated person interested in joining their Liver Team in a fast-paced, team and results-oriented work environment. As the Regulatory Affairs Program Manager, you will implement regulatory and strategic business requirements into whole organ program requirements including but not limited to, advising on applicable testing, managing documentation needs and timelines, and support, preparation, and execution of regulatory submissions. This program management role will focus on support for the liver whole organ regenerative medicine program taking a bioengineered liver from pre-clinical to first-in-human trials and ultimately a biological license application. The novelty of this regenerative medicine product will require flexibility, extrapolation, and a willingness to come up with and consider a broad spectrum of novel regulatory needs and solutions. You will need to leverage your existing biologics knowledge but not be confined to box-checking as we move into areas not directly contemplated by regulatory authorities. In this role, you will have primary program management responsibility for the whole bioengineered liver program, a completely novel human cell, tissue, and cellular and tissue-based product. You will need to collaborate cross-functionally to facilitate and meet all regulatory and business objectives within stated timelines. This role is a once-in-a-lifetime opportunity for the right regulatory professional to help hundreds of thousands of patients, by bringing a paradigm-changing, history-making human cell, tissue, and cellular and tissue-based therapeutic to market. What Youll Be Doing: Appropriately implement FDA regulations to ensure the compliant development and approval of biologic products. Develop, modify, and execute regulatory policies that affect immediate and future operations. Defining and executing tactical implementation plans working directly with the development team. Develop strategies and produce detailed regulatory plans and submissions including Pre-IND, IND, BLA and special designation requests. Effectively communicate regulatory needs to cross functional teams supporting biologic development and regulatory submission. Coordinate testing required to support regulatory approvals. Facilitate, prepare, and participate in meetings with regulatory agencies. Work closely with Clinical Specialist Medical Writers to direct writing needs including content and format. What You Have: Bachelors Degree (Masters or Ph.D. preferred) Minimum 8 years of biologic or pharma regulatory experience Minimum 5 years of project/people management experience Personal experience with successful regulatory submissions Proficient knowledge of FDA regulations, especially 21 CFR 1271 and 21 CFR 312
SENIOR REGULATORY AFFAIRS SPECIALIST The Cardiovascular portfolio delivers market leading technologies across the entire spectrum of cardiac and vascular care. The Structural Heart team develops and creates interventional devices and therapies to treat structural defects of the heart. This role will support transcatheter heart valve products within the Structural Heart team. Career That Change Lives The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapies to markets worldwide. Additionally, the Senior Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. A Day In The Life Define the regulatory strategy and manage regulatory submission activities for complex new product development activities and product maintenance for existing approved products. Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory affairs staff to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare regulatory submissions for new products and product changes, as required, to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager and negotiate submission issues with agency personnel. Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager. Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed. Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. Provide business and product information to international regulatory affairs staff to enable development of strategies and requirements and communicate that information to business teams. Provide feedback and on-going support to product development teams for regulatory issues and questions. Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work. Must Have; Minimum Requirements Bachelor's Degree Minimum of 4 years of regulatory experience or an advanced degree with a minimum of 2 years of regulatory experience. Nice to Have 4+ year medical device industry experience Degree in a scientific discipline (engineering, physical/biological or health sciences). Advanced degree - Regulatory Affairs Experience with Class III medical devices. History of successful 510(k)/IDE/PMA device product submissions and other worldwide submissions and clearances Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards Experience working with cross-functional teams. Experience working with technical documentation. Ability to comprehend principles of engineering, physiology, and medical device use. Ability to effectively manage multiple projects and priorities. Strong organizational skills and time management skills Excellent oral and written skills Excellent analytical thinking skills Effective team member Proficient computer skills About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)Additional Information Posting Date: Nov 10, 2020 Travel: Yes,
03/23/2021
Full time
SENIOR REGULATORY AFFAIRS SPECIALIST The Cardiovascular portfolio delivers market leading technologies across the entire spectrum of cardiac and vascular care. The Structural Heart team develops and creates interventional devices and therapies to treat structural defects of the heart. This role will support transcatheter heart valve products within the Structural Heart team. Career That Change Lives The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapies to markets worldwide. Additionally, the Senior Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes. A Day In The Life Define the regulatory strategy and manage regulatory submission activities for complex new product development activities and product maintenance for existing approved products. Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory affairs staff to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. Prepare regulatory submissions for new products and product changes, as required, to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager and negotiate submission issues with agency personnel. Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager. Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed. Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel. Provide business and product information to international regulatory affairs staff to enable development of strategies and requirements and communicate that information to business teams. Provide feedback and on-going support to product development teams for regulatory issues and questions. Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work. Must Have; Minimum Requirements Bachelor's Degree Minimum of 4 years of regulatory experience or an advanced degree with a minimum of 2 years of regulatory experience. Nice to Have 4+ year medical device industry experience Degree in a scientific discipline (engineering, physical/biological or health sciences). Advanced degree - Regulatory Affairs Experience with Class III medical devices. History of successful 510(k)/IDE/PMA device product submissions and other worldwide submissions and clearances Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards Experience working with cross-functional teams. Experience working with technical documentation. Ability to comprehend principles of engineering, physiology, and medical device use. Ability to effectively manage multiple projects and priorities. Strong organizational skills and time management skills Excellent oral and written skills Excellent analytical thinking skills Effective team member Proficient computer skills About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)Additional Information Posting Date: Nov 10, 2020 Travel: Yes,
Title: Regulatory Affairs Specialist Location: Sunnyvale, CA (This will be an onsite position) Term: 1 year contract opportunity The Regulatory Affairs Specialist will prepare the regulatory submissions and interact with Distributors, Regulatory Agencies and Health Authorities to obtain and maintain product approvals. ESSENTIAL JOB RESPONSIBILITIES: Prepare regulatory submissions for countries with focus on Latin America region Communicates with in-country Regulatory Affairs personnel to facilitate global clearances/approvals. Coordination with department personnel from regulatory, quality, and manufacturing sites, sales and marketing. Interact with global regulatory leaders and peers to expedite approval of pending registrations. Organizes and maintains files such as Responsibilities Matrix, Certificates from Notified Bodies CFS and CFG and other RA related material. Regulatory review and approval of design, manufacturing, labelling, packaging-related changes in compliance with applicable regulations and providing Regulatory Change Assessments through RCA . Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions. Education and Experience in years : Bachelor's degree in Life Science or related field with 2+ years of Quality or Regulatory experience -OR- Master's degree in in a Life Science or related field with 1-2 years of Quality or Regulatory work experience Knowledge and skills: Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations IVD product experience is highly preferred Prior knowledge of different databases like Trackwise, Agile documentation system is preferred. Experience in regulatory/Quality or related departments within an IVD or medical device industry Fluency in Spanish preferred Why Kelly ® ? Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly ® At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]
03/23/2021
Full time
Title: Regulatory Affairs Specialist Location: Sunnyvale, CA (This will be an onsite position) Term: 1 year contract opportunity The Regulatory Affairs Specialist will prepare the regulatory submissions and interact with Distributors, Regulatory Agencies and Health Authorities to obtain and maintain product approvals. ESSENTIAL JOB RESPONSIBILITIES: Prepare regulatory submissions for countries with focus on Latin America region Communicates with in-country Regulatory Affairs personnel to facilitate global clearances/approvals. Coordination with department personnel from regulatory, quality, and manufacturing sites, sales and marketing. Interact with global regulatory leaders and peers to expedite approval of pending registrations. Organizes and maintains files such as Responsibilities Matrix, Certificates from Notified Bodies CFS and CFG and other RA related material. Regulatory review and approval of design, manufacturing, labelling, packaging-related changes in compliance with applicable regulations and providing Regulatory Change Assessments through RCA . Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions. Education and Experience in years : Bachelor's degree in Life Science or related field with 2+ years of Quality or Regulatory experience -OR- Master's degree in in a Life Science or related field with 1-2 years of Quality or Regulatory work experience Knowledge and skills: Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations IVD product experience is highly preferred Prior knowledge of different databases like Trackwise, Agile documentation system is preferred. Experience in regulatory/Quality or related departments within an IVD or medical device industry Fluency in Spanish preferred Why Kelly ® ? Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly ® At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]
Kelly is currently seeking a Regulatory Affairs Specialist for a long-term engagement with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and you may be eligible for healthcare and retirement benefits and paid time off. OVERALL RESPONSIBILITIES: The Regulatory Affairs Specialist II is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy line of products. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Technical File, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation. The regulatory specialist is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes products for compliance to global regulations and company policies and procedures. DUTIES: • Prepare and/or assist in preparation of regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical File, Design Dossier, and Technical Documentation for submission to regional Health authorities. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase. • Assist in the preparation of approval documents to support rest of world registrations, such as EU CE marking activities, as required. • Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance. • Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance. • Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, MDR, etc.). • Perform other duties as assigned. PROFESSIONAL EXPERIENCE REQUIREMENTS: • Minimum 2 years of prior regulatory experience in medical devices, 5 years of experience preferred • Knowledge and/or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidances and standards • Knowledge of orthopedic implants a plus • Familiarity with G10 regulations and guidance a plus • Familiarity with electronic submission preparation a plus • Excellent written and oral communication skills • Ability to handle multiple tasks and be detail oriented EDUCATIONAL REQUIREMENTS: • BA/BS Degree required; advanced degree or equivalent work experience preferred Why Kelly ® ? Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly ® At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]
03/20/2021
Full time
Kelly is currently seeking a Regulatory Affairs Specialist for a long-term engagement with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and you may be eligible for healthcare and retirement benefits and paid time off. OVERALL RESPONSIBILITIES: The Regulatory Affairs Specialist II is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy line of products. This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Technical File, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation. The regulatory specialist is also responsible for the review and approval of all device labeling and product support information used in the promotion and educational activities of DePuy Synthes products for compliance to global regulations and company policies and procedures. DUTIES: • Prepare and/or assist in preparation of regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Technical File, Design Dossier, and Technical Documentation for submission to regional Health authorities. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase. • Assist in the preparation of approval documents to support rest of world registrations, such as EU CE marking activities, as required. • Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance. • Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance. • Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, MDR, etc.). • Perform other duties as assigned. PROFESSIONAL EXPERIENCE REQUIREMENTS: • Minimum 2 years of prior regulatory experience in medical devices, 5 years of experience preferred • Knowledge and/or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidances and standards • Knowledge of orthopedic implants a plus • Familiarity with G10 regulations and guidance a plus • Familiarity with electronic submission preparation a plus • Excellent written and oral communication skills • Ability to handle multiple tasks and be detail oriented EDUCATIONAL REQUIREMENTS: • BA/BS Degree required; advanced degree or equivalent work experience preferred Why Kelly ® ? Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly ® At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]
Source One Technical Solutions
East Hanover, New Jersey
Seeking a Regulatory Affairs Specialist for a consulting position at a pharmaceutical client in East Hanover, NJ. Qualifications: Education (minimum): BS or MS with requisite experience and demonstrated capability Languages: Fluency in English as a business language. Additional language is an asset Experience: 2-4 years experience mainly in a regulatory environment & closely related areas (eg; Clinical Development, GCP, QA) Skills: • Must have knowledge of global regulatory requirements • Understands and able to assist RA in understanding compliance and quality drivers from a global perspective, • Country regulatory/pharmaceutical experience from outside Europe or US • Use of IT systems • Experience and ability to work in matrix cross-functional environment • Excellent verbal and written communication skills. • Proven negotiation skills • Demonstrated ability as a creative thinker • Logical and methodical, with attention to details Job Requirements: Job Summary: As a member of the Registration Information Management (RIM) Team, responsible to support implementation of processes and procedures to ensure sustained compliance, at the global, regional and local level, with Health Authority regulations and internal company expectations regarding the capture and management of the registration information for the global company portfolio of products in current and upcoming systems. Responsibilities include: • With guidance, directs and monitors HQ and CO compliance with internal procedures governing registration information management activities at the global, regional and local level. Provides training as needed • Expert in RA Systems and related tools that support registration information management processes worldwide • Provides counsel and guidance to RA CO colleagues regarding their accountability in the registration information process • Supports the regulatory strategy and contributes to the implementation of RIM in collaboration with business owner and IT through e.g. data cleaning supervision on legacy systems, authoring of project-related documents etc.
01/31/2021
Full time
Seeking a Regulatory Affairs Specialist for a consulting position at a pharmaceutical client in East Hanover, NJ. Qualifications: Education (minimum): BS or MS with requisite experience and demonstrated capability Languages: Fluency in English as a business language. Additional language is an asset Experience: 2-4 years experience mainly in a regulatory environment & closely related areas (eg; Clinical Development, GCP, QA) Skills: • Must have knowledge of global regulatory requirements • Understands and able to assist RA in understanding compliance and quality drivers from a global perspective, • Country regulatory/pharmaceutical experience from outside Europe or US • Use of IT systems • Experience and ability to work in matrix cross-functional environment • Excellent verbal and written communication skills. • Proven negotiation skills • Demonstrated ability as a creative thinker • Logical and methodical, with attention to details Job Requirements: Job Summary: As a member of the Registration Information Management (RIM) Team, responsible to support implementation of processes and procedures to ensure sustained compliance, at the global, regional and local level, with Health Authority regulations and internal company expectations regarding the capture and management of the registration information for the global company portfolio of products in current and upcoming systems. Responsibilities include: • With guidance, directs and monitors HQ and CO compliance with internal procedures governing registration information management activities at the global, regional and local level. Provides training as needed • Expert in RA Systems and related tools that support registration information management processes worldwide • Provides counsel and guidance to RA CO colleagues regarding their accountability in the registration information process • Supports the regulatory strategy and contributes to the implementation of RIM in collaboration with business owner and IT through e.g. data cleaning supervision on legacy systems, authoring of project-related documents etc.
My client a provider of medical imaging and device products and services has an immediate opening for 2 Regulatory Affairs Specialist. Ideally commutable to any of the 3 locations, Wayne, NJ, Lexington, MA or Valhalla, NY. However client will consider a remote candidate. Must have experience with 510k submission pre-market and adverse event and recall experience post market. Level 1- requires 3 yrs. experience, salary is 85-90k. Level 2 requires 5yrs. experience , Salary is 95-11 0k and 8% bonus Maybe some flex on the salary Job Requirements: Bachelor Degree highly preferred/required Three to 5 or more years of hands on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) and U.S. FDA import/export/customs regulations Deep knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations) Excellent leadership, communication, collaboration, team work and interpersonal skills Perform Pre-Market U.S. FDA submissions (510(k) and PMA) in accordance with the product plan Provide feedback and recommendations to design teams regarding deciding when to submit a 510(k) for a change to an existing medical device Prepare European Union Technical Files and International Regulatory Submissions Evaluate all sources of incoming customer information, identify, investigate and document Customer Complaints, perform trend analysis and maintain all records Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action and maintain all records Coordinate all Mandatory Field Notifications, Engineering Change Orders, and Correction and Removals, take appropriate action and maintain all records Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action Perform Internal Audits and External Supplier Audits Coordinate U.S. FDA remediation activities Prepare Management Review Meeting presentations For complete JD or questions please contact Diane Hellickson
01/31/2021
Full time
My client a provider of medical imaging and device products and services has an immediate opening for 2 Regulatory Affairs Specialist. Ideally commutable to any of the 3 locations, Wayne, NJ, Lexington, MA or Valhalla, NY. However client will consider a remote candidate. Must have experience with 510k submission pre-market and adverse event and recall experience post market. Level 1- requires 3 yrs. experience, salary is 85-90k. Level 2 requires 5yrs. experience , Salary is 95-11 0k and 8% bonus Maybe some flex on the salary Job Requirements: Bachelor Degree highly preferred/required Three to 5 or more years of hands on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) and U.S. FDA import/export/customs regulations Deep knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations) Excellent leadership, communication, collaboration, team work and interpersonal skills Perform Pre-Market U.S. FDA submissions (510(k) and PMA) in accordance with the product plan Provide feedback and recommendations to design teams regarding deciding when to submit a 510(k) for a change to an existing medical device Prepare European Union Technical Files and International Regulatory Submissions Evaluate all sources of incoming customer information, identify, investigate and document Customer Complaints, perform trend analysis and maintain all records Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action and maintain all records Coordinate all Mandatory Field Notifications, Engineering Change Orders, and Correction and Removals, take appropriate action and maintain all records Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action Perform Internal Audits and External Supplier Audits Coordinate U.S. FDA remediation activities Prepare Management Review Meeting presentations For complete JD or questions please contact Diane Hellickson
SUMMARY DESCRIPTION The Regulatory Affairs Specialist will develop and implement regulatory strategies, focused on Orthopedic products and on achieving compliance with the upcoming European Medical Device Regulation. The Regulatory Affairs Specialist will be responsible for providing regulatory input and strategic direction for upgrading existing technical files and ensuring that new product are also compliant to the new requirements. Current business-critical projects include: product rationalization (part number reduction), revision and upgrading of existing Design History Files and other regulatory documents, transfer of product registrations between companies and strategic planning to ensure optimal business continuity. ESSENTIAL DUTIES AND RESPONSIBILITIES Using a broad base of knowledge and understanding of regulatory requirements, this person helps lead a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for our International business. Evaluates regulatory issues, develops regulatory strategies and revises technical documentation for upcoming regulatory submissions for orthopedic products. Develops US and International regulatory strategies and verification and validation activities for assigned product submissions Actively assists with our upcoming audits and certification reviews with Notified Body (BSI). Maintain Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements) Reviews promotional and advertising material for adherence to approved product claims. Works in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with European and International regulations. Coordinates roll-outs of product changes with corporate and international regulatory teams. Ensures timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators. DESIRED MINIMUM QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Any equivalent combination of education and experience that provides the applicant with the knowledge, skills, and abilities to perform the job is acceptable. EDUCATION Bachelors degree in science or other technically related field, or equivalent work experience. TYPE AND NUMBER OF YEARS OF EXPERIENCE Minimum of 5 years regulatory experience with increasing responsibility in a medical device or pharmaceutical company, or familiarity with orthopedic product development in a technical role. Experience in working effectively with cross-functional teams; especially with manufacturing sites. Experience with orthopedic or implantable products is preferred, but not required. Awareness of business strategies and tactics, including an understanding of regulatory impact. Must have proven ability to prepare and submit documents to regulatory agencies. Ability to explain regulatory requirements and pitfalls to project teams and colleagues. Can communicate existing facts in an organized and clear manner to cross-functional teams. Must be detail oriented, well-organized and able to work both independently and in teams. Must possess and demonstrate an understanding of FDA, MDR requirements and quality system requirements. Demonstrated sense of humor, and the capacity to enjoy working in a great team. SKILLS Must have strong writing, project management and communication skills. Demonstrated skills in contributing to multiple projects simultaneously. Awareness of business strategies and tactics, including regulatory impact. Can communicate facts in an organized and clear manner to cross-functional teams. Established skill in objective thinking. Provides regulatory input to cross-functional teams. Brings proposals for solutions to identified issues. Develops plans to meet pre-defined Regulatory goals. Responsible for tasks and simple submission components, based on templates Ability to explain regulatory requirements and pitfalls to project teams and colleagues. Capability to interact with diplomacy and tact while maintaining appropriate assertiveness. Willingness to take ownership and accept responsibility for actions and decisions. Must be detail oriented, well organized and able to work both independently and in teams. Ability to communicate effectively in both informal and formal settings. CERTIFICATION Regulatory Affairs Certification (RAC) is a plus, and can be obtained on the job. Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
01/31/2021
Full time
SUMMARY DESCRIPTION The Regulatory Affairs Specialist will develop and implement regulatory strategies, focused on Orthopedic products and on achieving compliance with the upcoming European Medical Device Regulation. The Regulatory Affairs Specialist will be responsible for providing regulatory input and strategic direction for upgrading existing technical files and ensuring that new product are also compliant to the new requirements. Current business-critical projects include: product rationalization (part number reduction), revision and upgrading of existing Design History Files and other regulatory documents, transfer of product registrations between companies and strategic planning to ensure optimal business continuity. ESSENTIAL DUTIES AND RESPONSIBILITIES Using a broad base of knowledge and understanding of regulatory requirements, this person helps lead a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for our International business. Evaluates regulatory issues, develops regulatory strategies and revises technical documentation for upcoming regulatory submissions for orthopedic products. Develops US and International regulatory strategies and verification and validation activities for assigned product submissions Actively assists with our upcoming audits and certification reviews with Notified Body (BSI). Maintain Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements) Reviews promotional and advertising material for adherence to approved product claims. Works in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with European and International regulations. Coordinates roll-outs of product changes with corporate and international regulatory teams. Ensures timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators. DESIRED MINIMUM QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Any equivalent combination of education and experience that provides the applicant with the knowledge, skills, and abilities to perform the job is acceptable. EDUCATION Bachelors degree in science or other technically related field, or equivalent work experience. TYPE AND NUMBER OF YEARS OF EXPERIENCE Minimum of 5 years regulatory experience with increasing responsibility in a medical device or pharmaceutical company, or familiarity with orthopedic product development in a technical role. Experience in working effectively with cross-functional teams; especially with manufacturing sites. Experience with orthopedic or implantable products is preferred, but not required. Awareness of business strategies and tactics, including an understanding of regulatory impact. Must have proven ability to prepare and submit documents to regulatory agencies. Ability to explain regulatory requirements and pitfalls to project teams and colleagues. Can communicate existing facts in an organized and clear manner to cross-functional teams. Must be detail oriented, well-organized and able to work both independently and in teams. Must possess and demonstrate an understanding of FDA, MDR requirements and quality system requirements. Demonstrated sense of humor, and the capacity to enjoy working in a great team. SKILLS Must have strong writing, project management and communication skills. Demonstrated skills in contributing to multiple projects simultaneously. Awareness of business strategies and tactics, including regulatory impact. Can communicate facts in an organized and clear manner to cross-functional teams. Established skill in objective thinking. Provides regulatory input to cross-functional teams. Brings proposals for solutions to identified issues. Develops plans to meet pre-defined Regulatory goals. Responsible for tasks and simple submission components, based on templates Ability to explain regulatory requirements and pitfalls to project teams and colleagues. Capability to interact with diplomacy and tact while maintaining appropriate assertiveness. Willingness to take ownership and accept responsibility for actions and decisions. Must be detail oriented, well organized and able to work both independently and in teams. Ability to communicate effectively in both informal and formal settings. CERTIFICATION Regulatory Affairs Certification (RAC) is a plus, and can be obtained on the job. Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
Summary: 5+ years of Regulatory Affairs experience Experience supporting Cosmetics and Over The Counter (OTC) filing Submission experience, Annual reports, IND, NDA, 510K Strong communication Experience working on small teams Product Information Files (PIF) Experience with Aerosols Regulation and labeling would be a plus. RESPONSIBILITIES: With light supervision, support product notification and registration for Shave, Skin and Wet Shave in Global regions (European) Assemble Product Information Files (PIF's) for Cosmetic Products being marketed in the European Union Prepare regulatory submissions to health authorities, assuring submissions meet relevant regulatory requirements. Review Artwork for Shave, Sun, Skin Preps and Wet Shave for Global regions. Confirm product or formula acceptability in local markets. Research and monitor changes in Regulation, Standards that may impact the business. Review Government and Retailer Regulatory surveys. Collaborate with Marketing, Program Management, Operations and other cross-functional team members to meet required deadlines. Maintain matrices and tracking sheets for Regulatory transactions. Help build matrix/playbook of Regulatory requirements for Consumer Products in Global Markets. Skills: Regulatory Affairs, Submission, NDA, FDA, File, Filing, OTC, Cosmetics, EU, Europe, PIF Top Skills Details: Regulatory Affairs Cosmetics and OTC BS / BA Degree Submission experience Experience Level: Intermediate Level About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
01/31/2021
Full time
Summary: 5+ years of Regulatory Affairs experience Experience supporting Cosmetics and Over The Counter (OTC) filing Submission experience, Annual reports, IND, NDA, 510K Strong communication Experience working on small teams Product Information Files (PIF) Experience with Aerosols Regulation and labeling would be a plus. RESPONSIBILITIES: With light supervision, support product notification and registration for Shave, Skin and Wet Shave in Global regions (European) Assemble Product Information Files (PIF's) for Cosmetic Products being marketed in the European Union Prepare regulatory submissions to health authorities, assuring submissions meet relevant regulatory requirements. Review Artwork for Shave, Sun, Skin Preps and Wet Shave for Global regions. Confirm product or formula acceptability in local markets. Research and monitor changes in Regulation, Standards that may impact the business. Review Government and Retailer Regulatory surveys. Collaborate with Marketing, Program Management, Operations and other cross-functional team members to meet required deadlines. Maintain matrices and tracking sheets for Regulatory transactions. Help build matrix/playbook of Regulatory requirements for Consumer Products in Global Markets. Skills: Regulatory Affairs, Submission, NDA, FDA, File, Filing, OTC, Cosmetics, EU, Europe, PIF Top Skills Details: Regulatory Affairs Cosmetics and OTC BS / BA Degree Submission experience Experience Level: Intermediate Level About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Regulatory Affairs Specialist - Charlotte, NC • Position: Regulatory Affairs Specialist • Placement: Direct Placement • Location: Charlotte, NC • Schedule: Monday - Friday • Shift: 1st • Pay: $65,000+ Annual Salary. Pay based upon experience Requirements: • 3 years of regulatory experience with SAP, LIMS and ChemPax. • 3 years of experience with customer interaction. • Experience creating and maintaining Safety Data Sheets (SDS) within the chemical industry. • Strong multi-tasking ability, responsiveness and reliability. Qualifications: • 3 years in chemical regulatory environment prefer previous interaction with government agencies. • Bachelor of Science in technical field - Major or focus in chemistry desired (or strong experience). • Previous experience interacting with customers on a regulatory basis- responding to customer inquiries via phone, email, and official documentation. • Experience creating and maintaining SDSs. Responsibilities: • Ensure compliance with all necessary regulations to assigned product lines. • Assist with import/export compliance. • Serve as back-up for all other regulatory tasks as needed. • Respond to customer inquiries concerning product compliance. • Enter product information into SAP and ChemPax systems. • Asses Product compliance. • Create/update product labels. • Create/update product SDS. • Enter supplier information into ChemPax. • Review exports for TSCA 12b needs and inform EPA of shipments as necessary • Assist EHS manager with any other regulatory duties as needed. • Maintain and communicate compliance in order to retain sales with customers. • Assist Sales & Marketing with presales regulatory and compliance customer inquiries. About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
01/30/2021
Full time
Regulatory Affairs Specialist - Charlotte, NC • Position: Regulatory Affairs Specialist • Placement: Direct Placement • Location: Charlotte, NC • Schedule: Monday - Friday • Shift: 1st • Pay: $65,000+ Annual Salary. Pay based upon experience Requirements: • 3 years of regulatory experience with SAP, LIMS and ChemPax. • 3 years of experience with customer interaction. • Experience creating and maintaining Safety Data Sheets (SDS) within the chemical industry. • Strong multi-tasking ability, responsiveness and reliability. Qualifications: • 3 years in chemical regulatory environment prefer previous interaction with government agencies. • Bachelor of Science in technical field - Major or focus in chemistry desired (or strong experience). • Previous experience interacting with customers on a regulatory basis- responding to customer inquiries via phone, email, and official documentation. • Experience creating and maintaining SDSs. Responsibilities: • Ensure compliance with all necessary regulations to assigned product lines. • Assist with import/export compliance. • Serve as back-up for all other regulatory tasks as needed. • Respond to customer inquiries concerning product compliance. • Enter product information into SAP and ChemPax systems. • Asses Product compliance. • Create/update product labels. • Create/update product SDS. • Enter supplier information into ChemPax. • Review exports for TSCA 12b needs and inform EPA of shipments as necessary • Assist EHS manager with any other regulatory duties as needed. • Maintain and communicate compliance in order to retain sales with customers. • Assist Sales & Marketing with presales regulatory and compliance customer inquiries. About Aerotek: We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Our client is looking for a stand out Regulatory Affairs Specialist. This is a 12 month contract with a large medical device company. In need of someone with: Bachelors Degree (bonus for BS) 2-5 experience in the regulatory industry Hands-on experience with submissions and knowledge of Class IIA, IIB, III products. Experience supporting domestic submissions, EU,and overseas registrations Job Requirements: The regulatory affairs specialist authors submissions to regulatory agencies for assigned geographies, supports worldwide registration and renewal efforts for Cardiac Surgery products, creates and maintains technical documentation for medical devices, and supports the change control process by performing regulatory assessments of product changes for assigned geographies along with communicating changes to geography-based RA counterparts.
01/30/2021
Full time
Our client is looking for a stand out Regulatory Affairs Specialist. This is a 12 month contract with a large medical device company. In need of someone with: Bachelors Degree (bonus for BS) 2-5 experience in the regulatory industry Hands-on experience with submissions and knowledge of Class IIA, IIB, III products. Experience supporting domestic submissions, EU,and overseas registrations Job Requirements: The regulatory affairs specialist authors submissions to regulatory agencies for assigned geographies, supports worldwide registration and renewal efforts for Cardiac Surgery products, creates and maintains technical documentation for medical devices, and supports the change control process by performing regulatory assessments of product changes for assigned geographies along with communicating changes to geography-based RA counterparts.