QARA Manager

Cure Talent are delighted to be partnered with an innovative medical device company developing novel technology ahead of a planned US launch in 2028. As they prepare for significant regulatory milestones, we have an exciting opportunity for a Regulatory Affairs & Quality Assurance Manager to join their growing team.

As the new RAQA Manager, you will lead global regulatory strategy and compliance activities, focusing on FDA De Novo submissions, Q-Sub interactions, and wider international registrations. Alongside this, you will 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.

Key Responsibilities

• 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, nonconformance, 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.

Experience and Skills Required

• 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.