Job Description
Kelly Science & Clinical is currently hiring a Remote Regulatory Affairs Specialist with MDR experience to support a long-term engagement at one of our Global Med Device clients - This is a remote position
This role is a full-time, fully benefitted position. As a Kelly employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You'll also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Job Goal:
Responsible for preparation of internal Regulatory documentation and various document types to be used in dossiers and labeling, both in paper and electronic formats, and responsibilities may extend to coordination, compilation, assembly, and publication of routine and complex regulatory dossiers and labeling, both in paper and electronic formats.
Job Function:
Performs final formatting and appropriate rendering of documents for filing and submission, including version control and document handling, to maintain regulatory compliance.
Follows established and/or creates new (as needed) standard operating procedures.
Responsible for maintaining all assigned work aids, etc.
Responsible for monitoring updates to HA regulations related to dossier formatting/assembly and assessing the impact on the business process.
Assists with the monthly reporting of data for established metrics.
Meets personnel paperwork due dates, e.g., timesheets.
Independently solves routine problems and develops solutions.
Recommends changes to current processes to make them more effective and efficient.
Responsibilities:
Prepares, dispatches and files routine Regulatory Affairs documentation, including but not limited to 30-day Notices, DTF, HA correspondence in paper and electronic format.
Collaborates with Regulatory Affairs staff to assure adequate prioritization, preparation and dispatch of routine regulatory submissions and/or labeling creation, such as 510(k)s and PMAs in paper and electronic format.
Prepares high quality submissions and labeling by editing and formatting documents while adhering to current regulatory guidelines, internal processes and procedures, style and document standards and utilizing company publishing tools, technology and systems.
Performs operational tasks including publishing, archiving and uploading of documents to document management systems; organizes and maintains components of regulatory submissions and labeling including template preparation, scanning, printing or filing.
Collects documents to import, edit and/or create in electronic documentation storage and retrieval systems.
Establishes and organizes electronic structures for local storage of regulatory submissions and/or labeling, including migration and maintenance of regulatory documents.
Participates on project teams for the publishing of regulatory documents and labeling creation.
Assists in preparing training materials and conducting training for users of electronic documentation systems and authors of regulatory documents.
Maintains document design consistency for all documents to ensure compliance with company document design standards, including the use and maintenance/creation of templates.
Helps drive process consistency and standards within assigned region.
Qualifications:
Associate or bachelor's degree; or 1-3 years of experience in regulatory affairs; or high school diploma or general education degree (GED) with 3 to 5 years related experience; and/or training or equivalent combination of education and experience.
Equipment usage and abilities needed:
Experience with regulatory processes and standards, including document standards and electronic document management systems (EDMS).
Working knowledge of Health Agency regulations for the assigned region and industry standards pertaining to regulatory operations.
Ability to work independently with regular supervision.
Strong organizational skills, accuracy and attention to detail
Ability to complete assigned tasks efficiently with some direction
A team player who is able to work in a fast-paced environment.
Understanding of guidelines and regulations around technical submission requirements for assigned region and/or deliverables.
Should possess a self-starting personality.
Software knowledge: Windows, MS Office (advanced skills required), Adobe Acrobat Professional (advanced skills required), ISI toolbox (advanced skills required), Octagon StartingPoint Templates (advanced skills required), Submissions publishing tools, XML and SML authoring tools, Labeling Management Systems
Why Kelly ® ?
As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work-just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.
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/non-traditional 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 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.
