Regulatory Affairs Lead

Job type: Permanent County: Cheshire Country: United Kingdom Salary/rate: £50,000 to £60,000 Discipline: Regulatory Job ref: CT3002 Post Date: 18-06-2026 05:23 PM Cure Talent is partnering with a global medical device company recognized for its life‑saving technologies. We have an opportunity for a Regulatory Affairs Lead to join their team in a hands‑on role supporting product portfolios. As the new Regulatory Affairs Lead, 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. You will work closely with senior stakeholders, provide mentorship to peers, and contribute to continuous improvement across regulatory processes. To be successful you will have proven experience operating in Regulatory Affairs within the medical device sector with detailed experience in EU MDR and US FDA frameworks, including Technical Documentation and 510(k) submissions. Hands‑on experience supporting international registrations, strong exposure to document review activities, and a solid understanding of clinical evaluation and post‑market requirements are required. Key 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. Experience And Skills Required 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. Contact Kris Holmes today or apply now. #J-18808-Ljbffr Cure Talent