Regulatory Affairs Manager

We're Hiring: Team Leader - Regulatory Affairs (IVD)

Edinburgh area Hybrid working available

A growing diagnostics innovator is building out its UK-based Regulatory Affairs team and looking for a Team Leader to help drive forward their global compliance efforts.

With 80 IVD products already on the market across the US, Canada, Europe, Australia, and more, the business is shifting from a split international model to a fully integrated RA function - covering pre-market, post-market, and continuous improvement activities from one central team.

About the Role

You'll lead a small team (including RA officers and admin staff), take ownership of regulatory input into product changes and compliance activities, and play a key role in embedding structure and clarity into the team's day-to-day operations. There's genuine scope for progression as the business grows.

Key Responsibilities

• Coordinate and oversee regulatory input for product changes and ongoing compliance work
• Mentor and support junior team members
• Liaise with manufacturing, QA, and project leads to ensure smooth project delivery
• Support submission planning and document updates for international registrations

What We're Looking For

• Strong working knowledge of IVD regulations (IVDD/IVDR essential)
• Exposure to global markets (FDA, Health Canada, etc. preferred)
• Proactive communicator with practical, solutions-oriented thinking
• Based within commuting distance or able to commit to regular time on-site

Salary: £60-65k (depending on experience)

Permanent, full-time

Hybrid flexibility - regular site presence preferred, especially in the early months