Regulatory Affairs Manager

🔍 We’re Hiring: Team Leader – Regulatory Affairs (IVD)

📍 Edinburgh area | Remote with occasional site visit

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

🔄 Remote flexibility