Regulatory Affairs Specialist

Location: Brookfield, Wisconsin, United States
Salary: competitive
Job Type: Permanent
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We are currently partnering with a Class II Medical Device Company with hiring a Regulatory Affairs Specialist. This is a permanent direct-hire position that is located in the Greater Milwaukee Area. This person will report into the Director of Quality.

The Regulatory Affairs Specialist will be responsible for supporting the life cycle management for these devices. This person should have extensive experienced with registrations and licensing products, supporting 510(k) submissions, and performing internal audits.

The ideal candidate will have a good balance of Regulatory and Quality experience in order to support cross-functional activities.

Requirements:

  • 4 Year Bachelor's Degree in life sciences
  • 3+ Years of Medical Device Experience in RA/QA
  • Experience supporting 510(k) Submissions, Author preferred
  • Experience with Internal Audits (ISO:13485 and MDSAP)
  • Experience with product registrations and licensing

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.

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