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- Tasks: Lead quality assurance and regulatory affairs for innovative wound dressing technology.
- Company: Join a dynamic startup focused on transforming wound care for better patient outcomes.
- Benefits: Enjoy flexible work hours, competitive salary, and equity options.
- 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 medical devices; strong leadership and communication skills required.
- Other info: Be part of a small team where your contributions will shine and be recognised.
The predicted salary is between 48000 - 72000 £ per year.
Our client is developing an advanced and innovative wound dressing platform (Advanced Tissue Repair Platform) to substantially 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. This role will have high visibility within the company, providing a chance to shine and be rewarded.
The Quality Assurance and Regulatory Affairs Director 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 WILL 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.
QARA / Quality Assurance and Regulatory Affairs Manager employer: Cpl Healthcare
Contact Detail:
Cpl Healthcare 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, especially ISO 13485 and FDA 21 CFR Part 820. 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, particularly those who have experience in regulatory affairs and quality assurance. 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 navigated regulatory submissions in your previous roles. Highlighting your hands-on experience will show that you 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. Being able to articulate how your skills align with their mission will set you apart and demonstrate your genuine interest in contributing to their success.
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 FDA regulations, ISO standards, and any specific experience with durable medical equipment.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for improving patient outcomes through innovative technologies. Mention your strategic leadership skills and how they align with the company's mission to disrupt the wound care industry.
Highlight Relevant Achievements: In your application, include specific examples of past successes in QA/RA roles, such as successful submissions to regulatory bodies or leading audits. Quantify your achievements where possible to demonstrate your impact.
Showcase Your Startup Experience: If you have experience working in a startup environment, make sure to highlight this in your application. Discuss how your hands-on, adaptable approach has contributed to previous projects, especially in fast-paced settings.
How to prepare for a job interview at Cpl Healthcare
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of FDA regulations, ISO standards, and the specific requirements for medical devices. Be prepared to discuss your experience with submissions like 510(k) and CE mark Technical Files, as this will demonstrate your expertise in navigating complex regulatory pathways.
✨Emphasise Your Leadership Skills
Given the high responsibility of this role, it's crucial to convey your leadership abilities. Share examples of how you've successfully led teams or projects in the past, particularly in a fast-paced environment. This will show that you can thrive in a startup culture and drive quality initiatives effectively.
✨Demonstrate Problem-Solving Abilities
Prepare to discuss specific challenges you've faced in quality assurance and regulatory affairs, and how you approached solving them. Highlight your proactive problem-solving mindset and attention to detail, as these traits are essential for the role.
✨Align with Company Values
Research the company's values and mission, and be ready to articulate how your personal values align with theirs. Showing that you resonate with their commitment to improving patient outcomes and your adaptability in a lean startup environment will make a strong impression.
