(2) Regulatory Specialist 2

1 month ago

Minneapolis, United States Custom Search Full time

Our mid-sized client is adding a Regulatory Affairs Specialist 2 to join their team. The Regulatory Affairs Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed. The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific products and ensures compliance with required regulations and established corporate standards.

Your role with the company:

  • Preparing documentation for international regulatory registrations and renewals.
  • Defining worldwide regulatory requirements necessary for regulatory approval of assigned products.
  • Executing product submission strategies as directed.
  • Maintaining all regulatory documentation to ensure availability for external audits and preparation of submission packages.
  • Maintaining a thorough knowledge of current regulatory requirements.
  • Executing on additional responsibilities as defined by management.
Desired Profile:
  • Bachelor's Degree in Science, Engineering, or other relevant discipline.
  • 4+ years' experience in Regulatory Affairs in the medical device industry.
  • 1-3 years' experience in international registrations.
  • Working knowledge of quality system regulations and guidelines.
  • Great communication skills with all levels of personnel.
  • High level of organization and planning skills.
  • Working knowledge of medical devices, procedures, and terminology.

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