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.