Regulatory Affairs Specialist

Location: Minneapolis, Minnesota, United States
Salary: US$45 - US$55 per hour + Medical, Dental, Vision
Job Type: Contract
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Are you an expert in Regulatory Affairs? Looking for your next opportunity at a company with innovative products and an exciting future? Look no further! My client a leading provider in medical device technologies in the Twin Cities area of Minnesota is now hiring for a Regulatory Affairs Specialist. This role will be slated as a 6 to 12-month contract.

Essential Duties:

  • Directs or performs coordination and preparation of document packages for international regulatory submissions
  • Leads or compiles all materials required in submissions
  • Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance

Education & Experience:

  • BA or BS in Biomedical, Biology, Chemistry or related field
  • 5+ years of technical experience; 2+ years in regulatory affairs for medical devices
  • Experience with EU MDR, remediation or submissions
  • Experience with Class II and III medical devices highly regarded

If this sounds like the right opportunity for you, please let me know what times you are available for an introductory phone call. I'd be happy to share further details and answer any of your questions.

Sthree US is acting as an Employment Business in relation to this vacancy.

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