Manager of Regulatory Affairs

Manager, Regulatory Affairs

The successful candidate is an experienced Regulatory Affairs management professional who is capable of managing all facets of RA for products. This includes authoring regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for domestic and international regulations, and interacting with governmental agencies. The position reports to the President/CEO.
Principal Duties and Responsibilities

  • Manages domestic and international regulatory submissions process. May author and publish electronic submissions.

  • Responds to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval.

  • Keeps all areas of company informed of regulatory requirements and emerging issues which may affect the registration approval of products.

  • Reviews proposed product changes for impact on regulatory status.

  • Writes, manages, and approves the development of package inserts/IFUs.

  • Reviews, evaluates, and approves promotion and advertising material for compliance with applicable regulations.

  • Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization.

  • Communicates with regulatory/governmental agencies.

BA degree
Five plus years of experience in medical device Regulatory Affairs, including preparation of submissions to the FDA/EU.

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