Head of Regulatory Affairs

GxPeople Global; Remote; GBP 80,000 - 110,000; Full time

Job summary

A high-growth healthcare Digital Health company is seeking a Head of Regulatory to lead global regulatory and quality strategy. This role involves owning the regulatory roadmap across UK, EU, and US while working closely with cross-functional teams. The ideal candidate will have a strong background in SaMD and AI medical device regulatory affairs, proven leadership skills, and the ability to adapt in fast-evolving environments. The position is fully remote, offering the chance to impact health technology on a global scale.

Qualifications

• Strong background in SaMD / AI medical device regulatory affairs.
• Experience operating in ambiguous or fast-evolving regulatory environments.
• Ability to work strategically and hands-on in a high-growth setting.

Responsibilities

• Own the global regulatory roadmap across UK, EU, US, and emerging markets.
• Lead global medical device regulatory strategy for SaMD / AIaMD.
• Partner with product and engineering teams to embed compliance into design and delivery.
• Manage and develop a specialist Compliance & Regulatory team.

Skills

Regulatory strategy

Cross-functional leadership

Experience in AI regulatory frameworks

Information security strategy

Compliance management

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.