Head of Regulatory Affairs

Head Regulatory

AI / Software as a Medical Device (SaMD)

UK-based | Remote

A high-growth healthcare Digital Health company with large-scale real-world deployments across the UK and US is hiring a Head of Regulatory to lead global regulatory and quality strategy.

The Role

You’ll own the global regulatory roadmap across UK, EU, US and emerging markets, combining strategic leadership with hands-on execution. You’ll lead a small, high-impact team while working closely with product, engineering, clinical, and commercial leadership.

Key Responsibilities

• Lead global medical device regulatory strategy for SaMD / AIaMD
• Navigate evolving and emerging AI regulatory frameworks
• Partner with product and engineering teams to embed compliance into design and delivery
• Own relationships with regulators, auditors, and notified bodies
• Lead information security strategy as the business scales
• Manage and develop a specialist Compliance & Regulatory team

Essential Experience

• Strong background in SaMD / AI medical device regulatory affairs
• Experience operating in ambiguous or fast-evolving regulatory environments
• Able to work strategically and hands-on in a high-growth setting
• Proven cross-functional leadership with product and engineering teams
• Startup or scale-up experience

Interested or know someone suitable?

Apply directly or message for a confidential discussion.