Quality Assurance Regulatory Affairs Manager

Cure Talent is partnered with an innovative medical device company developing novel technology ahead of a planned U.S. launch in 2028. As the company prepares for significant regulatory milestones, we have an exciting opportunity for a Regulatory Affairs & Quality Assurance Manager to join their growing team.

In this role, you will lead global regulatory strategy and compliance activities, focusing on FDA De Novo submissions, Q-Sub interactions, and wider international registrations. You will also oversee the Quality Management System in line with ISO 13485, managing the transition from a paper‑based system to an eQMS (Greenlight Guru), while acting as the Management Representative to senior leadership.

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• Lead and execute regulatory strategy to support market entry, including De Novo and 510(k) submissions and FDA Q‑Sub meetings.
  
• Prepare, review, and manage regulatory submissions and technical documentation in line with FDA, UK, and international requirements.
  
• Liaise directly with regulatory authorities, notified bodies, and external partners to support submissions, audits, and inspections.
  
• Maintain and improve the Quality Management System in compliance with ISO 13485 and 21 CFR Part 820.
  
• Lead the transition from a paper‑based QMS to an eQMS (Greenlight Guru).
  
• Oversee supplier management, CAPA, non‑conformance, change control, document management, and audit processes.
  
• Promote regulatory and quality awareness across the business and provide training to R&D and manufacturing teams.
  
• Act as Management Representative, reporting on QMS performance, risk areas, and quality objectives to senior leadership.
  
• Line‑manage and support QA staff responsible for day‑to‑day QMS maintenance and documentation.
  
• Review and approve documentation related to product development, validation, risk management, and sterilisation.
  

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• Proven experience in Regulatory Affairs and Quality Assurance within the medical device sector.
  
• Strong understanding of international frameworks and FDA pathways, including De Novo and 510(k).
  
• In‑depth knowledge of ISO 13485, 21 CFR Part 820, QMSR, ISO 14971, and ISO 9001.
  
• Experience leading or supporting QMS implementation projects, ideally eQMS (Greenlight Guru).
  
• Skilled in CAPA, audit management, risk management, validation, and change control.
  
• Excellent communication, organisation, and stakeholder management skills.
  
• Life sciences or engineering degree; relevant professional certifications advantageous.
  

If you’re an experienced RAQA professional seeking an opportunity to lead both regulatory strategy and QMS improvement for cutting‑edge medical technologies, we’d love to hear from you.