Head of Regulatory Affairs

GxPeople Global; Remote; GBP 125,000 - 150,000; Full time

Job summary

A high-growth digital health company in the UK seeks a Head of Regulatory to spearhead the global regulatory roadmap for software as a medical device. You will lead a small, impactful team while collaborating with product, engineering, and clinical functions. The ideal candidate will possess substantial experience in regulatory affairs, especially in SaMD, and be skilled in navigating complex regulatory landscapes. The role demands a strategic mindset with hands-on execution capabilities in a dynamic, fast-paced environment.

Qualifications

• Strong background in regulatory affairs for software as a medical device.
• Startup or scale-up experience is advantageous.
• Able to work strategically and hands-on in a high-growth setting.

Responsibilities

• Lead global regulatory strategy for software as a medical device.
• Navigate emerging AI regulatory frameworks.
• Partner with teams to embed compliance in product delivery.

Skills

Regulatory strategy leadership

Compliance embedding in design

Cross-functional leadership

Experience in ambiguous environments

Management of compliance team

Experience in SaMD / AI regulatory affairs

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.