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Senior Regulatory Affairs Specialist

  • Type Permanent
  • Salary US$99000 - US$130000 per annum + competitive
  • Location Eden Prairie, Minnesota
  • Sectors Regulatory Affairs

I am partnering with a Class II Medical Device company in the Twin Cities area with adding a Senior Regulatory Engineer Specialist to their team. This company is releasing new products to the market every six months and is growing at a healthy rate. This person will be the key liaison to the product development team and the Regulatory group.

The Senior Regulatory Affairs Engineer Specialist will provide the main Regulatory Strategy for the R&D teams. They are working on breaking software and hardware technologies to improve their legacy products. This person will be responsible for bringing these products to the U.S. and International markets with Regulatory submissions.

The Senior Regulatory Affairs Engineer Specialist must be able to work and communicate cross-functionally when giving Regulatory Strategy. They must be able to work independently on multiple projects and follow the timelines.

The Salary for this position is up to $130,000 depending on experience.

Please Read the following Requirements:

Education/Experience:

  • Bachelor's degree in Engineering
  • Master's in Regulatory Affairs or Engineer
  • 10+ years of Regulatory Affairs Experience, less with Higher Education

Expectations/Requirements:

  • Must have authored two or more 510(k)'s
  • Ability to work Cross-Functionally
  • Strong Understanding of FDA Regulations, International experience is a plus
  • Ability to work as an individual contributor but make an impact on the business

If you are interested in this opportunity please send me your update Resume and availability for us to speak. This phone screening process will begin May 31st

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