Quality Assurance Regulatory Affairs Manager

Cure Talent are delighted to be partnered with an established medical device manufacturer as they continue to strengthen their Quality and Regulatory capability. We have an exciting opportunity for a Quality & Regulatory Manager to join their leadership team and ensure ongoing compliance with global standards and regulations.

As the new Quality & Regulatory Manager, you will lead a small team and take responsibility for maintaining compliance with ISO 13485, MDR 2017/745, and other international frameworks. Acting as the Person Responsible for Regulatory Compliance (PRRC), you will oversee product registrations, QMS performance, technical documentation, and post-market activities, while driving a culture of quality and continuous improvement across the business.

Key Responsibilities

• Act as the Person Responsible for Regulatory Compliance
• Lead and mentor the QA/RA team, managing workloads, budgets, and resources effectively.
• Maintain compliance with ISO 13485 and other applicable international standards.
• Manage the preparation and maintenance of product registrations, technical documentation, and regulatory files.
• Oversee document control and ensure regulatory documentation meets all agency requirements.
• Plan and manage internal audit activities and drive continuous improvement initiatives.
• Lead CAPA, non-conformance, complaint handling, vigilance, and post-market surveillance processes.

Experience and Skills Required

• Proven QARA leadership experience within the medical device industry.
• Proven experience in UK, EU, US, and Canadian regulatory submissions.
• Strong working knowledge of ISO 13485, MDR 2017/745, and international quality standards.
• Experience managing quality teams and leading audits and inspections.
• Degree in Life Sciences or Engineering; microbiology or dermatology experience desirable.

If you’re an experienced QA/RA professional seeking a leadership opportunity to shape quality and regulatory strategy within an established medical device business, we’d love to hear from you.