Director Quality Assurance and Regulatory Affairs

Metric Bio; Greater London; Hybrid; GBP 75,000 - 100,000; Full time

Benefits offered by this job

Collaborative and supportive work culture

Opportunity to influence innovative medical devices

Job summary

A leading medical technology firm in Surrey is seeking a Director of Quality Assurance and Regulatory Affairs to shape the regulatory strategy and ensure compliance within a diverse medical device portfolio. The ideal candidate will have proven leadership experience in quality assurance and regulatory affairs, knowledge of international compliance, and a strong engineering or life sciences background. This full-time role offers a collaborative and innovative work environment.

Qualifications

• Proven leadership in QARA within medical devices or regulated industries.
• Experience with CE marking, EU/UK MDR, regulatory submissions.
• Skilled in stakeholder engagement and communication.

Responsibilities

• Shape and implement QARA strategy as part of senior management.
• Oversee global product registrations and maintain compliance.
• Manage and improve QMS; lead audits and CAPAs.

Skills

Proven leadership in QARA within medical devices or regulated industries

Experience with CE marking, EU/UK MDR, regulatory submissions

Skilled in stakeholder engagement and communication

Familiarity with eQMS and project management tools

Degree in Engineering, Life Sciences, or related

Experience liaising directly with regulatory bodies

Lead Auditor certification

Education

Degree in Engineering, Life Sciences, or related

Master's preferred

Job description

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