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Sr. RA Specialist

Are you passionate about Regulatory within the Medical Device Industry? Are you also interest in working in with emerging products for a small company? Well I have the right job for you! My client is medical device company located in Eagan, MN and is now looking to bring on a Sr. Regulatory Affairs Specialist. This person will be an expert with PMA, proficient with Medical Device Class lll or/and ll, knowledgeable with the EU MDR, FDA, and the Australian regulations. This role is a 6 months contract to hire with the ability to move up in the company.

The Sr. Regulatory Affairs Specialist requires someone who is can take charge of a project, write, author, and submit PMA.

Among others, the Sr. Regulatory Affairs Specialist will have the following responsibilities:

  • Knowledgeable of the Regulation in US, EU, and Australia
  • Communicate well with manufacturing team overbroad
  • Work on PMA for emerging products

The most desirable candidates will possess the following qualifications:

  • 10+ years of Regulatory Affairs in the Medical Device Industry
  • Knowledagable of Medical Device Class lll preferred but open to Class ll
  • Experienced with PMA in the US and EU, big plus with experience in Australia
  • The ability/experienced to work in a small company environment

If you meet the qualifications and interested in the Sr. Regulatory Affairs opportunity, please forward your current resume!

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