Medical Device Quality Specialist

3 weeks ago


London, Greater London, United Kingdom X4 Life Sciences Full time
Key Responsibilities
  • Developing Regulatory Strategies: Create and implement effective regulatory strategies to achieve FDA clearance and expand into other markets.
  • Managing QMS: Install and maintain a compliant QMS, including risk management processes, aligned with ISO 13485 and CFR21 Part 820.
  • Internal Audits and External Inspections: Oversee internal audits and manage external inspections by notified bodies and regulatory authorities.

The ideal candidate will have proven experience in QARA, familiarity with global medical device regulations, and experience with common international standards for electronic medical devices.



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