RAQA Manager

Cure Talent are delighted to be partnered with an innovative IVD medical device company based in Manchester. As they continue to grow and expand into new international markets, we have an exciting opportunity for an RAQA Manager to take ownership of their Quality and Regulatory functions.

As the new RAQA Manager, you will be the subject matter expert for Quality and Regulatory Affairs within a small, technically focused team. This is a senior, hands-on position rather than a traditional people management role, with responsibility for maintaining an established ISO 13485 QMS while leading the regulatory strategy, initially focused on IVDR certification before expanding into additional global markets.

To be successful as the RAQA Manager, you will be an experienced IVD or Medical Device professional with strong hands-on experience across both Quality Assurance and Regulatory Affairs. You will have proven knowledge of ISO 13485 and IVDR, including technical documentation, submissions and Notified Body interaction, alongside the confidence to operate independently as the QARA subject matter expert within a small, fast-moving organisation.

 Key Responsibilities

• Own, maintain and continuously develop the ISO 13485-certified Quality Management System.
• Lead IVDR technical file submissions and manage the ongoing Notified Body review and certification process.
• Take ownership of regulatory strategy and submissions across existing and future international markets, including the EU, US and Middle East.
• Work closely with R&D and Engineering on technical documentation, design history files and ongoing regulatory compliance.
• Lead key Quality activities including internal audits, CAPA and document control, acting as the primary QARA contact internally and externally.

 Experience and Skills Required

• Proven Quality and Regulatory Affairs experience within an IVD or Medical Device design and manufacturing environment.
• Strong hands-on experience with ISO 13485 and IVDR, including technical file preparation, submissions and Notified Body interaction.
• Demonstrable experience maintaining and developing an ISO 13485 Quality Management System.
• Comfortable taking ownership and operating autonomously as the QARA subject matter expert within a small organisation.
• Exposure to FDA or other international regulatory frameworks would be advantageous, with an IVD or diagnostics background preferred.

If you’re an experienced QARA professional looking for a role where you can take genuine ownership of Quality and Regulatory Affairs and help shape the international regulatory direction of a growing IVD business, please get in touch with Kris Holmes today!