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Senior Quality Compliance Specialist

7/10/2025

No location specified

Job Summary

A company is looking for a Senior Quality & Compliance Specialist (US, Remote).

Key Responsibilities
  • Plan, report, and monitor medical device field actions (corrections/removals) in compliance with global regulations
  • Manage U.S. State Drug and Medical Device Licensing, Establishment Registrations, and Device Listings
  • Coordinate compliance procedures, training, and systems for regulatory processes related to medical devices sold in the U.S
Required Qualifications
  • Bachelor's degree in a scientific or technical discipline or equivalent work experience
  • Minimum of 5 years of experience in Quality, Regulatory Affairs, or Regulatory Compliance related to medical devices or pharmaceuticals
  • Prior experience with medical device field actions and/or complaints and vigilance is preferred
  • Working knowledge of FDA and international regulations
  • General understanding of product development processes and regulations applicable to worldwide recalls and field actions

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