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- Tasks: Lead quality assurance and regulatory affairs for innovative medical devices.
- Company: Join a dynamic startup focused on transforming wound care with cutting-edge technology.
- Benefits: Enjoy a competitive salary, equity options, and flexible working hours.
- Why this job: Make a real impact in healthcare while growing your career in a supportive environment.
- Qualifications: 8-10 years in QA/RA roles, with expertise in medical devices and regulatory submissions.
- Other info: Be part of a small team where your contributions will be highly visible and valued.
The predicted salary is between 34000 - 50000 £ per year.
QARA / Quality Assurance and Regulatory Affairs Manager
QARA / Quality Assurance and Regulatory Affairs Manager
1 day ago Be among the first 25 applicants
Direct message the job poster from Cpl Life Sciences
Global Head of Engineering Recruitment, full product life cycle within Medical Devices, Scientific and Life Sciences.
Our client who is developing an advanced and innovative wound dressing platform (Advanced Tissue Repair Platform) to substantially, will improve the clinical outcome for patients with Chronic and Complex Wounds whilst maintaining simplicity for care providers.
Our Client is on a mission to improve the current standard of care to reduce the physical and psychological impact of poor wound healing on patients that suffer from these wounds.
Our clients team is small, so this role will have high risibility within the company so a chance to shine and be rewarded. Our client prides themselves on being a pragmatic, a lean start-up that’s driven to deliver world-changing technologies at pace and responding to challenges flexibly and rapidly. Proud of their company values and live them every day:
JOB SUMMARY
The Quality Assurance and Regulatory Affairs Manager will be responsible for developing, implementing, and maintaining quality and regulatory systems in compliance with FDA, ISO, and other global regulatory standards. This role requires deep experience in medical device development — particularly durable medical equipment — combined with working knowledge of regenerative therapies and their evolving regulatory pathways.
The ideal candidate will thrive in a fast-paced startup environment and bring strategic leadership, cross-functional collaboration, and executional excellence.
ESSENTIAL RESPONSIBILITIES
⬢ Develop and maintain a robust Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and applicable standards.
⬢ Lead internal and external audits, CAPA processes, non-conformance investigations, and change control.
⬢ Oversee design control, risk management (ISO 14971), and product lifecycle quality from R&D to post-market surveillance.
⬢ Establish and monitor key quality metrics and provide executive-level reporting.
⬢ Ensure supplier and contract manufacturer compliance through audits, qualification, and continuous monitoring.
⬢ Define and lead global regulatory strategy for the company’s medical device and regenerative medicine products.
⬢ Prepare and submit CE mark Technical Files, FDA submissions (510(k), IDE, PMA) and other international regulatory dossiers.
⬢ Serve as the primary regulatory liaison with notified bodies, FDA and other global regulatory authorities.
⬢ Monitor changes in the regulatory landscape (e.g., FDA, EMA, MDR) and advise leadership on compliance risks and opportunities.
⬢ Support clinical and preclinical study design from a regulatory perspective
THE IDEAL CANDIDATE HAVE
⬢ A bachelor’s degree in engineering, life sciences, or a related field.
⬢ Minimum of 8-10 years of experience in QA/RA roles within the medical device industry.
⬢ Proven experience with durable medical equipment (DME) and familiarity with regenerative medicine (e.g., synthetic biodegradable polymers, HCT/Ps, combination products).
⬢ Direct experience preparing and submitting successful EU MDD and/or MDR and, FDA PMAs.
⬢ Deep understanding of ISO 13485, FDA QSR, MDSAP, EU MDR, and related standards.
⬢ A startup mentality: self-starter, hands-on, resourceful, and adaptable.
⬢ Demonstrated strong leadership and team-building abilities.
⬢ Excellent communication and cross-functional collaboration skills.
⬢ A strategic thinker mindset with attention to detail and a proactive problem-solving approach.
IN RETURN OUR CLIENT OFFERS
⬢ A chance to shape the quality and regulatory foundations of a company disrupting the wound care industry.
⬢ Competitive salary and equity package.
⬢ Flexible work environment and schedule.
⬢ Opportunity for significant professional growth and leadership development.
Seniority level
-
Seniority level
Director
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance
-
Industries
Medical Equipment Manufacturing
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Wrexham, Wales, United Kingdom £40,000.00-£50,000.00 4 hours ago
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QARA / Quality Assurance and Regulatory Affairs Manager employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QARA / Quality Assurance and Regulatory Affairs Manager
✨Tip Number 1
Familiarise yourself with the latest FDA and ISO regulations relevant to medical devices. Being well-versed in these standards will not only boost your confidence during interviews but also demonstrate your commitment to compliance and quality assurance.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in QA/RA roles. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully led quality management initiatives or regulatory submissions in your previous roles. Highlighting your hands-on experience will set you apart as a candidate who can thrive in a fast-paced startup environment.
✨Tip Number 4
Research our client’s innovative wound dressing platform and understand its impact on patient care. Showing genuine interest in their mission and how your skills align with their goals will make a strong impression during the interview process.
We think you need these skills to ace QARA / Quality Assurance and Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance and regulatory affairs, particularly within the medical device industry. Emphasise your familiarity with ISO 13485, FDA regulations, and any specific projects related to durable medical equipment.
Craft a Compelling Cover Letter: In your cover letter, express your passion for improving patient outcomes through innovative medical solutions. Mention how your background aligns with the company's mission and values, and provide examples of your leadership and problem-solving skills in previous roles.
Highlight Relevant Achievements: When detailing your work experience, focus on specific achievements that demonstrate your ability to develop and maintain quality management systems, lead audits, and navigate regulatory submissions. Use metrics where possible to quantify your impact.
Showcase Your Startup Experience: If you have experience working in a startup environment, make sure to highlight this. Discuss how you adapted to fast-paced changes and contributed to cross-functional teams, as this aligns well with the company's culture and expectations.
How to prepare for a job interview at Cpl Life Sciences
✨Understand Regulatory Standards
Make sure you have a solid grasp of the key regulatory standards such as ISO 13485 and FDA QSR. Be prepared to discuss how your experience aligns with these standards and how you've implemented them in previous roles.
✨Showcase Your Leadership Skills
Since this role requires strong leadership, think of examples where you've successfully led teams or projects. Highlight your ability to collaborate cross-functionally and how you've driven quality initiatives in a fast-paced environment.
✨Prepare for Technical Questions
Expect technical questions related to quality management systems and regulatory submissions. Brush up on your knowledge of CAPA processes, risk management, and design control to demonstrate your expertise.
✨Demonstrate a Startup Mentality
This position is within a lean startup, so convey your adaptability and resourcefulness. Share experiences that illustrate your proactive problem-solving approach and how you've thrived in dynamic settings.
