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Regulatory Affairs Manager

3 months ago

Canton, United States Catalyst Life Sciences Full time

Opportunity to join a global medical instrumentation organization as they grow the regulatory team due to successful acquisitions and increases to their product portfolio. Focusing on existing products, you'll have global reach on ensuring they remain compliant with US, EU IVDR, and global regulations.


Responsibilities:

  • Lead and coordinate the transition of the IVD products from current regulations to IVDR requirements.
  • Interpret and apply IVDR guidelines to ensure product compliance as an individual contributor.
  • Develop regulatory strategies and provide guidance on IVDR implementation to project teams.


Experience Required

  • Bachelor's degree in a scientific or technical discipline; advanced degree preferred.
  • Minimum 4 years of experience in regulatory affairs within the medical device industry, with specific expertise in IVDs and knowledge of IVDR.
  • Proven experience in preparing and submitting regulatory filings (e.g., CE Marking, FDA submissions).
  • Strong understanding of IVDR requirements and their application to IVD products.