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 and implementation of regulatory strategies for new diagnostic products and the wider IVD programme.
• Support regulatory activities across risk management, performance evaluation, post-market surveillance and product compliance.
• Work closely with Scientific, Data, R&D and Quality teams to ensure regulatory requirements are understood and incorporated throughout product development.

Experience and Skills Required

• Proven Regulatory Affairs experience within the Medical Device or IVD industry, with an IVD or diagnostics background strongly preferred.
• Strong hands-on experience developing, maintaining and reviewing technical documentation.
• Good working knowledge of UK and European Medical Device regulations, with experience of MDR and/or IVDR.
• Experience supporting regulatory activities across product development, risk management, performance evaluation or post-market activities.
• Comfortable working independently within a smaller organisation and engaging directly with multidisciplinary technical teams.
• Experience with software, bioinformatics, genomic diagnostics or SaMD would be advantageous but is not essential.

If you're an experienced Regulatory Affairs professional looking for a hands-on role where you can take genuine ownership, work closely with a highly technical team and help support the next stage of a growing diagnostics business, please get in touch with Kris Holmes today

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