Regulatory Affairs & Quality Assurance Manager

Cure Talent is working with an innovative medical device start-up based in Oxfordshire, developing advanced medical technology for use in hospital and clinical environments. As the business progresses towards commercialisation, they are looking to appoint a Regulatory Affairs & Quality Assurance Manager to take ownership of regulatory and quality activities.

This is a hands-on position within a small, multidisciplinary team, offering the opportunity to influence how regulatory and quality processes are developed as the company grows.

As the new RAQA Manager, you will work closely with engineering, product development and senior leadership, supporting the development of an ISO 13485-compliant Quality Management System, maintaining technical documentation and ensuring regulatory requirements are considered throughout the product development lifecycle.

What will you be doing?

• Developing, implementing and maintaining the company's ISO 13485 Quality Management System.

• Preparing and maintaining technical documentation in accordance with EU MDR and UK medical device regulations.

• Supporting regulatory strategy, conformity assessment and preparation for CE and UKCA marking.

• Working closely with engineering teams to implement design controls, risk management and verification and validation processes.

• Managing internal audits, CAPA, non-conformances, supplier quality and management reviews.

• Supporting product development activities, including design reviews, change control and design transfer.

• Coordinating external audits and interactions with Notified Bodies and other regulatory stakeholders.

• Establishing practical quality processes that support product development and future commercialisation.

What are we looking for?

• 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.

• Hands-on experience developing or maintaining medical device technical documentation.

• Experience implementing or improving Quality Management Systems within a regulated environment.

• A good understanding of design controls, verification and validation and medical device product development.

• Experience with active medical devices, electromechanical systems or complex medical equipment would be particularly relevant.

• The confidence to work independently, influence technical colleagues and balance regulatory requirements with the practical needs of a developing business.

Experience supporting a medical device through CE marking, working with Notified Bodies or establishing regulatory and quality processes within a start-up would be advantageous.

The opportunity

This position would suit an experienced RAQA professional who enjoys working close to the technology and wants to take ownership of regulatory and quality activities rather than managing an established department.

You'll join a growing MedTech business at an important stage of development, with the opportunity to shape its quality systems, support regulatory approvals and contribute directly to bringing new medical technology to market.

Interested?

Apply today or contact Cure Talent for a confidential discussion about the position.