Head of Regulatory Affairs

GxPeople Global; Remote; GBP 80,000 - 120,000; Full time

Job summary

A high-growth healthcare digital health company is seeking a Head of Regulatory to lead the global regulatory roadmap for SaMD and AI medical devices. This role involves managing a compliance team, navigating evolving regulatory frameworks, and working closely with product and engineering teams. The ideal candidate has strong leadership experience in regulatory affairs, especially in high-growth or startup environments, and is capable of working strategically and hands-on across multiple markets.

Qualifications

• Ability to lead global regulatory strategy across multiple jurisdictions.
• Experience with startup or scale-up companies.
• Strong background in compliance and regulatory affairs.

Responsibilities

• Lead the global regulatory roadmap for SaMD / AIaMD.
• Navigate emerging AI regulatory frameworks.
• Manage and develop a specialist compliance and regulatory team.

Skills

Leadership in regulatory affairs

Expertise in SaMD / AI medical device

Ability to navigate evolving AI regulations

Cross-functional collaboration

Experience in high-growth environments

Job description

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
• 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.