Senior Regulatory Affairs Specialist

Location: Burnsville, Minnesota, United States
Salary: competitive
Job Type: Permanent
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We are currently partnering with an emerging Medical Device company with hiring a Senior Regulatory Affairs Specialist to join the team. This is a permanent direct-hire position that will report to the Vice President of Regulatory Affairs and Quality. This company is located in the Southern Metro of the Twin Cities.

The Senior Regulatory Affairs Specialist will be responsible for supporting the full life-cycle management of Class I, Class II, and Class III Medical Devices. This is a global role and the Senior Regulatory Affairs Specialist will support submissions to the FDA, EU, and other OUS Countries. The company has a healthy pipeline of new product development and this person will support de novo submissions.

It is an exciting time to join a growing organization. This person will have a high level of visibility to Senior Leadership and will be able to implement their own original Regulatory Strategies.

This company is able to virtually interview and on-board.

Requirements:

  • 5+ Years of Regulatory Affairs Experience with Class II/Class III Devices
  • Experience with 510(k) and PMA Submissions - Author Preferred
  • Proven experience of working cross-functionally with Quality/Engineering/Clinical
  • Self-Starter that is motivated to grow with the company

If you are interested, please send me your updated resume. Interviews will begin next week.

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

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