Regulatory Affairs & Quality Assurance Manager

Cure Talent is partnered with a growing medical device start-up developing connected, active medical technology for use in hospital and homecare environments. With product development progressing and commercialisation activities underway, they are looking to recruit a Regulatory Affairs & Quality Assurance Manager.

This is a fully remote UK position, with occasional travel for team meetings, audits and product development activities.

The role combines hands-on Regulatory Affairs and Quality Assurance responsibilities, providing an opportunity to take ownership of the company's regulatory compliance and quality management activities while working closely with its engineering and leadership teams.

Key Responsibilities

• Maintain and develop the company's ISO 13485 Quality Management System.

• Prepare and maintain technical documentation in accordance with EU MDR and UK regulatory requirements.

• Support regulatory submissions, product registrations and interactions with external regulatory bodies.

• Work closely with engineering teams on design controls, risk management and verification and validation activities.

• Coordinate internal audits, supplier quality activities, CAPA and management reviews.

• Support post-market surveillance, complaint handling and regulatory reporting requirements.

• Provide regulatory and quality input into product development and design changes.

Experience and Skills Required

• Proven experience across both Regulatory Affairs and Quality Assurance within the medical device industry.

• Strong working knowledge of ISO 13485, EU MDR and ISO 14971.

• Experience supporting technical documentation and regulatory submissions.

• Practical understanding of design controls and product development within a regulated environment.

• Experience with active medical devices, connected devices or integrated hardware and software systems.

• Confidence working independently within a small, cross-functional organisation.

This opportunity would suit an experienced RAQA professional who enjoys combining regulatory and quality responsibilities and wants to play a central role in bringing innovative medical technology to market.

Interested?

Apply today or contact Cure Talent for a confidential discussion.