Head of Regulatory Affairs

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

Job summary

A healthcare technology firm is seeking a Head of Regulatory to lead global regulatory and quality strategy. This role involves owning the regulatory roadmap across key markets, managing a specialist team, and navigating evolving AI regulatory frameworks. Ideal candidates will have a strong background in SaMD regulations, proven cross-functional leadership skills, and the ability to thrive in a fast-paced, high-growth environment. This position offers remote work flexibility within the UK.

Qualifications

• Proven track record in regulatory and quality strategy within healthcare.
• Strong background in leading small teams effectively.
• Ability to work in a high-growth company setting.

Responsibilities

• Lead global medical device regulatory strategy for SaMD / AIaMD.
• Manage relationships with regulators, auditors, and notified bodies.
• Drive the information security strategy as the business scales.

Skills

Strategic leadership

Cross-functional leadership

Experience in SaMD / AI medical device regulatory affairs

Ability to navigate evolving regulatory frameworks

Experience in fast-evolving regulatory 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.