Regulatory Affairs Manager

JR United Kingdom; Dunfermline; Hybrid; GBP 60,000 - 65,000; Full time

Job summary

Une entreprise innovante dans le domaine des diagnostics recrute un Team Leader en affaires réglementaires pour diriger son équipe au Royaume-Uni. Ce rôle implique de gérer des activités de conformité réglementaire pour des produits IVD bien établis sur plusieurs marchés internationaux, avec des perspectives de progression.

Qualifications

• Connaissance des réglementations IVDD/IVDR essentielle.
• Expérience avec des marchés globaux (FDA, Santé Canada, etc.) souhaitée.
• Capacité à encadrer et à soutenir des membres juniors de l'équipe.

Responsibilities

• Coordonner et superviser l'entrée réglementaire pour les changements de produits.
• Mentorer et soutenir des membres juniors du groupe.
• Collaborer avec fabrication, QA et responsables de projets pour assurer une livraison fluide.

Skills

Connaissance des réglementations IVD

Communication proactive

Pensée orientée solutions

Job description

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? 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