Regulatory Affairs Specialist

Location: Minneapolis, Minnesota, USA
Salary: US$80000 - US$90000 per annum + competitive
Job Type: Permanent

We are currently partnering with a Global Medical Device company with hiring a Regulatory Affairs Specialist to join their team. This is a Class II Medical Device company located in St. Paul, Minnesota. The Regulatory Affairs Specialist will report to the Senior Director of Regulatory Affairs.

The Regulatory Affairs Specialist will support the Life-Cycle Management for multiple product lines. This is a global position and this person will interact with various Regulatory Agencies. This person will be responsible for Global Regulatory Submissions such as 510(k)'s and CE Marking. This company has seen significant growth and continues to invest in New Product Development to grow their product lines.

That Salary Range for this Position is $80,000 - $90,000 + Bonus

Here are the Requirements/Expectations:


  • 4 Year Bachelor's Degree, Life Sciences Preferred
  • Higher Education is a plus


  • 3+ Years of Regulatory Affairs Experience with Class II Medical Devices
  • Extensive 510(k) and CE Mark experience, Authorship preferred
  • Experience with MDD/MDR 2020 Regulations
  • Life-cycle Management Experience
  • Global Regulatory Affairs Experience, FDA and EU are a must
  • Must have an entrepreneurial mind-set and a passion for Regulatory

If you, or anyone you know, are interested in this position please send me an updated version of your resume and availability for a phone screen.

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