Head of SaMD Regulatory & AI Compliance

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

Job summary

A high-growth healthcare Digital Health company is seeking a Head of Regulatory to lead global regulatory and quality strategy. This role involves owning the regulatory roadmap across UK, EU, and US while working closely with cross-functional teams. The ideal candidate will have a strong background in SaMD and AI medical device regulatory affairs, proven leadership skills, and the ability to adapt in fast-evolving environments. The position is fully remote, offering the chance to impact health technology on a global scale.

Qualifications

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

Responsibilities

• Own the global regulatory roadmap across UK, EU, US, and emerging markets.
• Lead global medical device regulatory strategy for SaMD / AIaMD.
• Partner with product and engineering teams to embed compliance into design and delivery.
• Manage and develop a specialist Compliance & Regulatory team.

Skills

Regulatory strategy

Cross-functional leadership

Experience in AI regulatory frameworks

Information security strategy

Compliance management

Job description

A high-growth healthcare Digital Health company is seeking a Head of Regulatory to lead global regulatory and quality strategy. This role involves owning the regulatory roadmap across UK, EU, and US while working closely with cross-functional teams. The ideal candidate will have a strong background in SaMD and AI medical device regulatory affairs, proven leadership skills, and the ability to adapt in fast-evolving environments. The position is fully remote, offering the chance to impact health technology on a global scale.