Head of Regulatory Affairs

GxPeople Global; Remote; GBP 150,000 - 200,000; Full time

Job summary

A fast-growing healthcare digital health company is looking for a Head of Regulatory to lead their global regulatory and quality strategy. This remote role involves owning the regulatory roadmap across UK, EU, US, and emerging markets, while managing a specialist Compliance & Regulatory team. The ideal candidate will have a strong background in SaMD / AI medical device regulatory affairs, experience navigating evolving regulatory environments, and proven leadership in high-growth situations.

Qualifications

• Strong background in SaMD / AI medical device regulatory affairs.
• Experience navigating fast-evolving regulatory environments.
• Ability to work strategically and hands-on in high-growth settings.

Responsibilities

• Lead global medical device regulatory strategy for SaMD / AIaMD.
• Manage relationships with regulators, auditors, and notified bodies.
• Lead the regulatory and quality strategy globally.

Skills

Leadership

Regulatory strategy

Compliance knowledge

Cross-functional teamwork

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.