Regulatory Affairs Lead

Cure Talent; Crewe; On-site; GBP 60,000 - 80,000; Full time

Job summary

Cure Talent is thrilled to partner with a global medical device company seeking a Regulatory Affairs Lead in Crewe. This hands-on role involves supporting regulatory activities, with a focus on document review and international registrations. Candidates should have proven experience in Regulatory Affairs and familiarity with EU MDR and US FDA frameworks.

The successful candidate will oversee regulatory strategy, perform comprehensive document reviews, and guide submissions across various markets. Mentorship within a small team will also be part of the responsibilities.

Qualifications

• Proven experience in Regulatory Affairs within the medical device sector.
• Strong understanding of EU MDR and US FDA frameworks.
• Hands-on experience in international registrations and document review.

Responsibilities

• Define regulatory strategy for product portfolios.
• Lead review of regulatory documentation and submission dossiers.
• Support global submissions for EU MDR and US FDA 510(k).
• Act as regulatory contact within cross-functional teams.
• Monitor regulatory developments influencing product activities.

Skills

Regulatory Affairs experience

EU MDR knowledge

US FDA frameworks

Document review

Submission preparation

Job description

Cure Talent are delighted to be 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.

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 as the new Regulatory Affairs Lead, 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. You will have hands‑on experience supporting international registrations, strong exposure to document review activities, and a solid understanding of clinical evaluation and post‑market requirements.

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.