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- Tasks: Lead global quality and regulatory strategy for innovative medical devices.
- Company: Global leader in medical technology, dedicated to improving lives.
- Benefits: Competitive salary, hybrid work options, and a mission-driven culture.
- Other info: Collaborative environment with opportunities for professional growth.
- Why this job: Make a real impact in healthcare while shaping regulatory strategies.
- Qualifications: Proven leadership in QARA and experience with regulatory submissions.
The predicted salary is between 48000 - 72000 £ per year.
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
Director Quality Assurance and Regulatory Affairs in London employer: Metric Bio
Contact Detail:
Metric Bio Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Quality Assurance and Regulatory Affairs in London
✨Tip Number 1
Network like a pro! Reach out to people in the medical technology sector, especially those who work in quality assurance and regulatory affairs. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of CE marking and EU/UK MDR regulations. Show us you know your stuff and can lead the charge in compliance and quality management!
✨Tip Number 3
Don’t just wait for job postings; be proactive! Check our website regularly and apply directly. We love seeing candidates who take the initiative to join our mission-driven team.
✨Tip Number 4
Practice your storytelling skills. Be ready to share specific examples of how you've led teams or improved quality systems in past roles. We want to hear how you can make an impact in our organisation!
We think you need these skills to ace Director Quality Assurance and Regulatory Affairs in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Director Quality Assurance and Regulatory Affairs role. Highlight your experience in QARA, especially in medical devices, and showcase any relevant certifications or leadership roles you've held.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this position. Share specific examples of how you've shaped QARA strategies or led teams in the past, and don't forget to express your passion for improving lives through medical technology.
Showcase Your Regulatory Knowledge: Since this role involves overseeing global product registrations and compliance, make sure to highlight your familiarity with CE marking, EU/UK MDR, and ISO standards. We want to see that you know your stuff when it comes to regulatory affairs!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates about the hiring process!
How to prepare for a job interview at Metric Bio
✨Know Your Regulations
Make sure you brush up on the latest regulations like CE marking and EU/UK MDR. Being able to discuss these in detail will show your expertise and readiness for the role.
✨Showcase Your Leadership Skills
Prepare examples of how you've led teams in quality assurance and regulatory affairs. Highlight specific projects where your leadership made a difference, as this role requires strong strategic leadership.
✨Familiarise Yourself with the Company
Research Metric Bio and their products. Understanding their mission and how they impact healthcare will help you align your answers with their goals during the interview.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or quality assurance issues. Practising your responses to these scenarios can help you demonstrate your problem-solving skills effectively.