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For Companies At a Glance
- Tasks: Lead quality assurance and regulatory strategies for innovative medical devices.
- Company: Join a dynamic startup revolutionising 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; experience with medical devices and regulatory submissions required.
- Other info: Be part of a small team where your contributions will be highly visible and valued.
The predicted salary is between 43200 - 72000 £ per year.
Overview
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 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 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.
Apply
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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 Quality Assurance and Regulatory Affairs Manager
✨Tip Number 1
Familiarise yourself with the latest regulations and standards in the medical device industry, especially ISO 13485 and FDA guidelines. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the quality assurance and regulatory affairs sectors. Attend industry conferences or webinars where you can meet potential colleagues or mentors who can provide insights into the company culture and expectations.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your leadership and problem-solving skills. Highlight instances where you've successfully navigated regulatory challenges or improved quality management systems.
✨Tip Number 4
Research the company's products and their impact on wound care. Understanding their mission and how your role as a Quality Assurance and Regulatory Affairs Manager can contribute to their goals will set you apart as a candidate who is genuinely interested in the position.
We think you need these skills to ace 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 in the medical device industry. Emphasise your familiarity with ISO standards and any specific achievements related to compliance and audits.
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 Experience: In your application, clearly outline your experience with durable medical equipment and regenerative therapies. Provide examples of successful submissions to regulatory bodies like the FDA and CE mark, as this will demonstrate your expertise.
Showcase Soft Skills: Don’t forget to mention your soft skills such as communication, collaboration, and problem-solving. These are crucial in a small team environment where cross-functional collaboration is key to success.
How to prepare for a job interview at Cpl Life Sciences
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of FDA, ISO, and other global regulatory standards. Be prepared to discuss specific experiences where you successfully navigated these regulations in previous roles.
✨Demonstrate Leadership Skills
Since this role requires strong leadership abilities, come ready with examples of how you've led teams or projects in the past. Discuss how you foster collaboration and drive results in a fast-paced environment.
✨Prepare for Technical Questions
Expect technical questions related to quality management systems and medical device development. Brush up on ISO 13485 and FDA QSR, and be ready to explain how you've applied these standards in your work.
✨Emphasise Your Startup Mentality
The company values a startup mentality, so share instances where you've been resourceful and adaptable. Highlight your ability to thrive in dynamic environments and how you approach problem-solving proactively.
