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
Salary description
£60000.00 - £75000.00 per year