Director Quality Assurance and Regulatory Affairs

Director Quality Assurance and Regulatory Affairs

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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

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