Senior Quality Compliance Specialist

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