Quality Assurance and Regulatory Affairs Manager

ZipRecruiter; Port Talbot; On-site; GBP 65,000 - 75,000; Full time

Job summary

Une entreprise dynamique dans le secteur médical recherche un Responsable Assurance Qualité et Affaires Réglementaires pour diriger leurs systèmes de qualité et garantir la conformité réglementaire. Le candidat idéal aura une solide expérience en dispositifs médicaux et sera capable de travailler dans un environnement de startup, apportant un leadership stratégique et une collaboration interfonctionnelle.

Qualifications

• Minimum de 8 à 10 ans d'expérience en QA/RA dans l'industrie des dispositifs médicaux.
• Expérience directe avec des équipements médicaux durables et connaissance des thérapies régénératives.
• Excellentes compétences en communication et en collaboration interfonctionnelle.

Responsibilities

• Développer et maintenir un système de gestion de la qualité conforme aux normes ISO 13485 et FDA.
• Diriger des audits internes et externes et gérer les processus CAPA.
• Définir et diriger la stratégie réglementaire mondiale pour les produits.

Skills

Leadership

Collaboration interfonctionnelle

Résolution de problèmes

Attention aux détails

Education

Baccalauréat en ingénierie, sciences de la vie ou domaine connexe

Job description

Job Description

Job Title: Quality Assurance and Regulatory Affairs Manager

Job Type: Permanent

Location: Port Talbot, Wales, UK – On site/Remote

Remuneration: £65,000 - £75,000

Cpl Life Sciences is partnering with a small but growing medical device company 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.

The team is small, and they pride themselves on being a pragmatic, lean start-up that’s driven to deliver world-changing technologies at pace and responding to challenges flexibly and rapidly.

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.

You MUST be based in the UK and be able to get to the site in Wales.

For more information, please reach out to [e-mail]