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- Tasks: Lead global quality and regulatory strategy for innovative medical devices.
- Company: Global leader in medical technology, focused on improving lives.
- Benefits: Competitive salary, hybrid work options, and a mission-driven culture.
- Why this job: Make a real impact in healthcare while shaping regulatory strategies.
- Qualifications: Proven leadership in QARA and experience with regulatory submissions.
- Other info: Collaborative environment with opportunities for professional growth.
The predicted salary is between 72000 - 108000 £ per year.
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.
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
Director Quality Assurance and Regulatory Affairs 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
✨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. Use LinkedIn to connect and engage with industry professionals; you never know who might have a lead on your dream job!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of CE marking and ISO standards. Be ready to discuss how you've led teams and managed compliance in previous roles. Show them you're not just a fit for the role but a perfect match for their mission-driven culture.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds and shows your professionalism.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows your genuine interest in joining our innovative team at Metric Bio.
We think you need these skills to ace Director Quality Assurance and Regulatory Affairs
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 leadership experience in QARA and any relevant regulatory submissions you've managed. We want to see how your skills align with our mission!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in medical devices and how you can contribute to our innovative team. Keep it concise but impactful, and let your personality show!
Showcase Relevant Experience: When detailing your experience, focus on specific achievements in quality management systems and regulatory compliance. We love numbers, so if you’ve improved processes or led successful audits, make sure to include those stats!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people. Don’t miss out!
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 confidently will show that you’re not just familiar with the standards but also understand their implications for the company’s products.
✨Showcase Your Leadership Skills
Prepare examples of how you've led teams in quality assurance and regulatory affairs. Highlight specific instances where your strategic leadership made a difference, especially in managing compliance or improving processes.
✨Understand the Company’s Mission
Research Metric Bio and its commitment to improving lives through medical technology. Be ready to discuss how your values align with theirs and how you can contribute to their mission of precision engineering and regulatory excellence.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific regulatory challenges or quality assurance issues. Think through potential scenarios and prepare structured responses that demonstrate your problem-solving skills and experience.