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.