Regulatory Affairs Lead

About the role

The role spans the full product lifecycle, with a strong focus on document review, international registrations, and helping to define regulatory strategy for new and existing products across all classes of device, including Class III.

Responsibilities

• Helping to define regulatory strategy across assigned product portfolios, ensuring alignment with business and market access objectives.
• Lead and perform detailed review of regulatory documentation, including Technical Documentation, Clinical Evaluation Reports and submission dossiers.
• Prepare, review and support global submissions including EU MDR and US FDA 510(k), as well as wider international registrations.
• Act as a key regulatory contact within cross-functional teams, providing guidance on classification, clinical pathways and conformity assessment routes.
• Support regulatory interactions, including responses to authority queries, audits and inspections.
• Monitor regulatory developments and assess impact to ongoing and future activities.
• Provide mentorship and guidance within the team, supporting development without direct line management responsibility.

Requirements

• Proven experience within Regulatory Affairs in the medical device sector.
• Strong working knowledge of EU MDR and US FDA frameworks, including Technical Documentation and 510(k) submissions.
• Experience helping to define regulatory strategy alongside hands-on submission and documentation activity.
• Exposure to international registrations across multiple markets is advantageous.
• Experience with clinical evaluation and post-market clinical follow-up activities is desirable.

Skills

• Hands-on experience supporting international registrations.
• Strong exposure to document review activities.
• Solid understanding of clinical evaluation and post-market requirements.