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Senior Manager of Regulatory Affairs (Remote)

We are currently recruiting a Senior Manager of Regulatory Affairs to join our team. This person will support Class II Devices and IVD products. This is a direct-hire permanent position that will report to the Director of Regulatory Affairs. This company's headquarters in the Greater Boston Area, but can work 100% remotely.

The Senior Manager of Regulatory Affairs will be responsible for supporting a Global Regulatory Strategy for Class II and IVD products. This person will manage a team to support the life-cycle management of these devices. This person should have a strong submissions background with 510(k)'s and in depth understanding of IVD's.

The Senior Manager of Regulatory Affairs will have global responsibilities for the United States, Health Canada, LATAM, APAC, and other geographic regions. This person should have strong leadership experience and able to lead and grow their team. The Senior Manager will work with cross-functional leaders to help develop and sustain the product line.

The Salary for this position is up to $140,000 + Bonus

Here are some of the Requirements:

Education:

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

Experiences/Expectations:

  • 5+ Years of Regulatory Experience with IVD's
  • 3+ Years of Leadership Experience within Regulatory
  • Author of Multiple 510(k)'s and IDE's
  • History creating a Successful Global Regulatory Strategy
  • Cross-Functional Background with Quality, Clinical, and R&D

If you are interested in this opportunity please send me your updated resume and availability for a phone screen.

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