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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