Head of Regulatory Affairs

GxPeople Global; Remote; GBP 70,000 - 90,000; Full time

Job summary

A high-growth healthcare Digital Health company is seeking a Head of Regulatory to drive the global regulatory roadmap for SaMD/AI medical devices. This role involves leading a team while collaborating with product, engineering, and clinical sectors to ensure compliance within design and delivery. Candidates should have a strong regulatory background, particularly in AI medical devices, and be adept at managing teams in a fast-paced environment. The position is remote, allowing applicants across the UK.

Qualifications

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

Responsibilities

• Lead global medical device regulatory strategy for SaMD / AIaMD.
• Navigate evolving and emerging AI regulatory frameworks.
• Partner with product and engineering teams for compliance.

Skills

Global regulatory strategy

AI regulatory frameworks

Cross-functional leadership

Information security strategy

Medical device 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.