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Regulatory Affairs Manager

  • Job type Permanent
  • Salary US$99000 - US$150000 per annum + competitive
  • Location Woodbury, Minnesota
  • Sector Regulatory Affairs

I am partnering with a Class II Medical Device Company in the Greater Twin Cities Area to add a Regulatory Affairs Manager to their team. This company is a smaller Medical Device company that has gone through the Start-Up phase and is expanding into new markets. They are working on innovative technology that is making a major impact on the health system.

The Regulatory Affairs Manager will report to the CTO of the company and work laterally with the Directory of Quality and Compliance. We are looking for someone who is strong in Regulations and has the mentality to work in the small company atmosphere. The Regulatory Affairs Manager will be able to make a direct impact on the entire business acting as the Regulatory Subject Matter Expert. They will provide Regulatory Strategy in order to bring their Devices into new markets.

The Regulatory Affairs Manager will be responsible for providing Regulatory Support for new products and maintaining Legacy products. As the company grows they will be responsible for making sure the Regulations are met for different countries. This person should also have a good understanding of upcoming changes such as MDR 2020/GDPR as well as Global Quality Systems.

Salary Range: $125,000 - $150,000

Please see the following Requirements:

Education:

  • Bachelor's Degree, Life Sciences Preferred
  • Higher Education is a Plus

Experience/Expectations:

  • 5+ years of Regulatory Experience within Medical Device Industry
  • Authorship of 510(k)'s
  • Must have experience with software/sensor technology and Cyber Security
  • Directly Communicated with FDA
  • Strong understanding of FDA Regulations and OUS Regulations
  • Ability to Understand and Support Global Quality Management Systems
  • Experience with developing Regulatory Strategy
  • Experience working cross-functionally to bring products to market

Interviews for this position will be happening the first full week of June. If you are interested please send me your updated Resume and time that you are available to speak with me about the position.

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