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 – lucy.kirkaldy@cpl.com
This role does not offer sponsorship; you must hold the full right to work
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