Director Quality Assurance and Regulatory Affairs
This range is provided by Metric Bio. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
Direct message the job poster from Metric Bio
Role overview
Director of Quality Assurance & Regulatory Affairs (QARA)
Surrey, UK – This role is on-site, with hybrid (1 or 2 days/week) possible after the probation period.
About the Company
A global leader in the medical technology sector, developing advanced cryopreservation and incubation equipment that supports clinicians, embryologists, and specialist clinics worldwide. The organisation is committed to improving lives through precision engineering and regulatory excellence.
Role Purpose
Lead the company’s global quality and regulatory strategy, ensuring compliance across a diverse medical device portfolio and enabling market access.
Key Responsibilities
- Strategic Leadership: Shape and implement QARA strategy; act as part of senior management; embed quality and compliance across the lifecycle.
- Regulatory Affairs: Oversee global product registrations (CE, MDR, FDA, international markets); determine regulatory pathways; maintain compliance with ISO 13485 and other relevant standards.
- Quality Assurance: Manage and improve QMS; lead audits and CAPAs; analyse QA metrics to drive improvement.
- Project Oversight: Manage regulatory documentation and audit readiness; oversee change control and PMS.
- Team Development: Mentor QARA team; ensure training aligns with current regulations.
Skills & Experience
- Proven leadership in QARA within medical devices or regulated industries.
- Experience with CE marking, EU/UK MDR, regulatory submissions, electrical safety, software validation, and international compliance.
- Skilled in stakeholder engagement and communication.
- Familiarity with eQMS and project management tools.
- Degree in Engineering, Life Sciences, or related (Master’s preferred).
- Experience liaising directly with regulatory bodies.
- Lead Auditor certification.
Why Apply
- Influence the regulatory direction of an innovative medical device portfolio.
- Be part of a mission-driven company making a global impact in healthcare.
- Collaborative, supportive, and innovative work culture.
Seniority level
- Director
Employment type
- Full-time
Job function
- Quality Assurance
Industries
- Medical Equipment Manufacturing
#J-18808-Ljbffr…