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Senior Regulatory Affairs Specialist

Senior Regulatory Affairs job available with a Medical Device company in the east side of Minneapolis MN.

As the Senior Regulatory Affairs Specialist you will be responsible for:

  • Management and maintenance of technical files for class I and class II devices.
  • Management of your own products and product lines and fully manage the regulatory life cycle including product registrations.
  • Writing submissions for international and US market.
  • Project work as needed includes but not limited to, labelling reviews & changes, exposure to EU MDR & MDD.

Requirements:

  • Bachelors Degree
  • Regulatory affairs experience with technical files for class I and class II devices
  • Experience writing 510Ks and other international submissions

If you are interested and meet the requirements please apply with your resume and Real Staffing with reach out to discuss the opportunity further ahead of submitting to the client.

This is a permanent direct hire role.

Salary is depending on experience level.

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