Regulatory Affairs Lead

Permanent role based in Cheshire, United Kingdom with a salary range of £50,000 to £60,000.

About the role

We are partnered with a global medical device company recognised for its life-saving technologies. As they continue to expand their portfolio, we have an opportunity for a Regulatory Affairs Lead to join their team in a hands-on role supporting product portfolios. You will operate as a senior individual contributor within a team of three, supporting regulatory activities while remaining heavily involved in execution. 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

• Help 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.