Head of Regulatory Affairs

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

Job summary

A high-growth healthcare Digital Health company is hiring a Head Regulatory to lead global regulatory and quality strategy. This remote role involves owning the global regulatory roadmap, navigating emerging AI regulatory frameworks, and managing a Compliance & Regulatory team. Ideal candidates will have a strong background in SaMD regulatory affairs and experience in fast-evolving environments. This position requires strategic leadership combined with hands-on execution in a dynamic startup setting.

Qualifications

• Strong background in SaMD / AI medical device regulatory affairs.
• Experience in ambiguous or fast-evolving regulatory environments.
• Proven ability to work strategically and hands-on.

Responsibilities

• Lead global medical device regulatory strategy for SaMD / AIaMD.
• Navigate evolving and emerging AI regulatory frameworks.
• Own relationships with regulators, auditors, and notified bodies.
• Lead information security strategy as the business scales.

Skills

SaMD / AI medical device regulatory affairs

Cross-functional leadership

Strategic and hands-on execution

Experience in fast-evolving regulatory environments

Startup or scale-up experience

Job description

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.