Global RA/QA Director - Medical Devices Compliance & Quality

Posted yesterday

rxfunctionEden Prairie (MN)

Regulatory Affairs Managers Electromedical and Electrotherapeutic Apparatus Manufacturing

SENIORITY

Manager

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About the role

RxFunction, Inc. seeks a seasoned Director of Regulatory Affairs and Quality Assurance to lead our global regulatory strategy and QMS for emerging medical device initiatives. You will interact with the FDA and Notified Bodies, develop regulatory strategies, and manage submissions while guiding QA across development, transfer to production, and post-market activities. The role requires 15+ years in RA/QA in medical devices, with deep ISO 13485 and 21 CFR Part 820 knowledge, and the ability to

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