Regulatory Affairs Professional 3
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Newark, DE 19702
Commercial Title: Regulatory Affairs Professional
Regulatory Affairs Specialist supports changes to commercial in vitro diagnostic reagents and consumables at company or prepare and submit product related regulatory submissions to international Regulatory Affairs team members. Responsibilities include:
· Assesses and documents regulatory impact of design and manufacturing process changes for commercial products.
· Communicates with Regional regulatory teams to determine global regulatory impact.
· Participates in Change Review Board representing Regulatory function.
· Reviews and approves project documentation and labeling
· As needed, prepares/submits 510(k)s, 510(k) notes to file, PMA 30 Day notices, supplements and annual reports, and updates IVDD documentation.
· Maintains awareness of U.S. and global regulatory legislation and assesses impact to ongoing projects.
· Identifies, analyzes and implements country specific requirements necessary for product related submissions.
· Plans and prepares product related submissions with Client’s internal (e.g. Regional Units) or external organizations according to regulatory requirements.
· Performs regulatory projects or acts as a member of the project steering group.
· Submits required documentation/information to local authorities or Client’s internal.
Required Knowledge / Skills, Education and Experience
· Bachelor’s degree in related discipline
· Strong leadership, interpersonal, communication and organizational skills required. Must possess a high level of critical and strategic thinking skills and be a detail oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities. Must be able to set priorities as well as adapt to changing priorities.
· Demonstrates knowledge of organization’s business practices and issues
· 5-8 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge; advanced degree MAY be substituted for some years of experience, where applicable.
· Experience with IVD industry and/or FDA submission experience. Knowledge and experience with global registrations a plus.