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Sr. RA Specialist

Are you passionate about Regulatory Affair within the Medical Device Industry? Are you also interest in working with an amazing company that offers great opportunities? Well I have the right job for you! My client is a well-recognized medical device company in the Minneapolis area, and is now looking to hire a Senior Regulatory Affair Specialist. This person will be very experience with writing 510k and have a clear understanding of the EU Regulations. The role is a 3 month contract that will pay $100+ per hour based on prior experience.

The Senior Regulatory Affairs Specialist requires everything from writing 510k to doing submission and will have some flexibility to work remotely.

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

  • Writing 510k
  • Understanding of FDA regulations and EU Regulations
  • Submission Strategies
  • Change Order Reviews

The most desirable candidates will possess the following qualifications:

  • 5+ years of Regulatory experience
  • EU MDR experience or understanding
  • Software or hardware experience

This is a wonderful opportunity to join a well-known medical device company that offers great development.

If you are interesting in the Senior Regulatory Affairs Specialist opportunity, please forward your current resume and/or contact me on the details below!

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