Regulatory Submission Lead - Medical Devices

Regulatory Submissions Lead

Location: UK (remote)

Salary: Up to £80,000

Cpl Life Sciences is partnering with a small but growing medical device business that has recently secured funding and is now looking to hire a Regulatory Submissions Lead to support its next phase of growth. This is a hands-on role with real ownership — ideal for someone who enjoys working across strategy and execution in a fast-moving environment.

You’ll be responsible for leading regulatory submissions across the UK, EU, and US, including FDA 510(k), De Novo, and Q-Subs, while acting as a key point of contact for regulators and notified bodies. Alongside submissions, you’ll play a big part in shaping regulatory strategy, ensuring compliance across the full product lifecycle, and supporting the business as it expands into new markets.

Key Responsibilities

• Lead global regulatory submissions (FDA, EU MDR, UKCA)
• Prepare and manage 510(k), De Novo and FDA pre-submissions
• Represent the business in FDA and regulatory authority interactions
• Develop regulatory strategies, including classification and market pathways
• Carry out gap analysis on technical documentation and clinical evidence
• Maintain clinical evaluation reports (CERs) and technical files
• Review product claims, labelling and promotional material
• Support post-market surveillance and regulatory compliance activities
• Work closely with Quality, Clinical, R&D and commercial teams

What We’re Looking For

• Around 10+ years of experience in medical device regulatory affairs
• Strong knowledge of EU MDR and FDA requirements
• Experience with 510(k), De Novo, and Q-Sub processes
• Comfortable working cross-functionally and influencing stakeholders
• Able to balance detail with a practical, commercial mindset

Additional Information

• Must be based in the UK and have the right to work in the UK
• Fully remote role

For more information, please reach out -

This role does not offer sponsorship; you must hold the full right to work