Regulatory Affairs Specialist

7 days ago


Chaska, Minnesota, United States Compunnel Inc. Full time

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Compunnel Inc. in the biotechnology industry.

Job Summary:

As a Regulatory Affairs Specialist, you will be responsible for coordinating post-market regulatory programs and ensuring compliance with global regulations.

Key Responsibilities:

  • Support global registration efforts across various regions, including the EU, Canada, Brazil, Latin America, and Asia Pacific.
  • Interpret and apply federal, state, and international regulations to products and processes.
  • Liaise with regulatory bodies and resolve compliance issues.
  • Prepare and submit regulatory reports, licenses, and listings.
  • Manage regulatory clearances, device listings, and import/export requirements.
  • Maintain regulatory intelligence and ensure ongoing compliance.

Requirements:

  • 3-5 years of experience in Diagnostic Regulatory Affairs, with knowledge of IVD/IVDR.
  • Experience in global registrations across various regions.
  • Bachelor's degree with 5 years of relevant experience, or equivalent advanced degree.
  • Background in medical devices, pharmaceuticals, or in-vitro diagnostics preferred.
  • Strong communication and prioritization skills.
  • Experience with LEAN principles and risk management (FMEA/HHA) is a plus.
  • RAC certification preferred.


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