Regulatory Affairs Manager

Cure Talent are delighted to be partnered with a growing diagnostics company based near Cambridge. As they continue to progress their existing medical devices and move towards the next stage of their IVD development programme, we have an exciting opportunity for a Regulatory Affairs Manager to join their established Quality and Regulatory team. As the new Regulatory Affairs Manager, you will take ownership of the hands-on day-to-day Regulatory Affairs activities, working closely with the Head of QA/RA and wider Scientific, Data and Technical teams. This is a practical, delivery-focused position, supporting existing UKCA and CE marked products while helping progress new diagnostic tests and the company''s longer-term IVD regulatory programme. To be successful as the Regulatory Affairs Manager, you will be an experienced Medical Device or IVD Regulatory professional with strong hands-on experience across technical documentation, product lifecycle activities and regulatory compliance. You will be comfortable working within a smaller, cross-functional environment, able to take ownership of your work while collaborating directly with technical and scientific colleagues to move projects forward. Key Responsibilities Maintain, review and develop technical documentation for existing and future Medical Device and IVD products. Support UKCA and CE marking activities, including product changes, lifecycle management and updates to regulatory documentation. Contribute to the development ..... full job details .....