Regulatory Affairs Manager

Regulatory Manager / Medical Devices (UK, Hybrid)

This one’s for the regulatory people who actually enjoy being close to the product.

I’m working with a UK-based medtech company building a connected medical device that’s already in use and heading into its next regulatory phase.

They’re looking for a Regulatory Manager who’s comfortable sitting at the intersection of Regulatory and Quality shaping strategy, owning submissions, and being the calm, credible voice when auditors, engineers and founders all want answers.

What you’d actually be doing

• Owning regulatory strategy across the product lifecycle
• Leading and coordinating submissions 510(k) experience essential and MDR desirable as this will be next)
• Being the go-to person for auditors, notified bodies and regulators
• Keeping the QMS tight, usable, and fit-for-purpose (ISO 13485, CAPA, risk, design controls)
• Working closely with R&D, software, clinical and leadership, not sat in a silo
• Helping shape how Quality & Regulatory scales as the product and business grow

The experience that matters

• Solid medical device regulatory background (5+ years is the right ballpark)
• FDA experience (successfully submitted a 510(k) submission
• Software / connected device exposure is useful, not a blocker if you’ve worked closely with software teams
• Confident communicator, you don’t disappear when questions get uncomfortable

A few important bits

• Hybrid working - One day a week on-site (Mondays)
• Seniority and scope to grow with the business
• Open to permanent — and potentially contract
• Salary flexible for someone who genuinely fits the brief
• UK candidates only - No sponsorship offered.