Job Title: Senior Specialist Regulatory Affairs - Project Manager
Location: 1300 East Touhy Ave, Des Plaines, IL - 60018
Duration: 10+ months (possible extension)
Hiring Manager notes:
EXPERIENCE/BACKGROUND
- Minimum 5 years - Demonstrated experience at a supervisory/managerial level.
- Prior experience in medical device and thorough knowledge of clinical research and/or regulatory affairs preferred. Academic or in-house courses in leadership, training, Continuous Improvement (CI), cycle time improvement, etc., are preferred. RAPS certification, preferred.
- Experience working in a broader enterprise/cross division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Ability to multi-task, prioritize and meet deadlines in timely manner. Ability to plan strategically and work independently. Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- Ability to travel approximately 15-25%, including internationally
PURPOSE OF ROLE
- This position has primary management responsibility directly or through lower management levels for the preparation and submission of product approval applications. Works with regulatory agencies to obtain timely approvals of all products. Recommends, interprets and implements companywide policies and procedures to accomplish assignments and resolves a broad range of issues and problems. Ensures employee compliance with such policies, practices and procedures and is responsible for continuous process improvement. Assures that quality of services meets internal and external customer requirements.
MAIN RESPONSIBILITIES
- Sets strategy and directs preparation of submissions for products to regulatory agencies, and interfaces with agencies in order to obtain timely approval to produce and market new products.
- Provides guidance on regulatory requirements and strategies to product development project teams.
- Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decisionmaking; communicates such knowledge to all internal stakeholders.
- Consults with and provides advice to senior management of the Company on strategies and plans for regulatory product approvals.
- Directs staff in implementing regulatory strategy and preparing regulatory submissions.
- Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
- Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
- Performs related functions and responsibilities, on occasion, as assigned.
- Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
- Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Thanks & Regards,
Mridul Singh
Talent Acquisition Specialist
Experis CORE+
Phone: Ext: 7192
Text:
Email:
Linkedin:
100 Manpower Place, Milwaukee WI 53212