Head of SaMD Regulatory & AI Compliance

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

Job summary

A fast-growing healthcare digital health company is looking for a Head of Regulatory to lead their global regulatory and quality strategy. This remote role involves owning the regulatory roadmap across UK, EU, US, and emerging markets, while managing a specialist Compliance & Regulatory team. The ideal candidate will have a strong background in SaMD / AI medical device regulatory affairs, experience navigating evolving regulatory environments, and proven leadership in high-growth situations.

Qualifications

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

Responsibilities

• Lead global medical device regulatory strategy for SaMD / AIaMD.
• Manage relationships with regulators, auditors, and notified bodies.
• Lead the regulatory and quality strategy globally.

Skills

Leadership

Regulatory strategy

Compliance knowledge

Cross-functional teamwork

Job description

A fast-growing healthcare digital health company is looking for a Head of Regulatory to lead their global regulatory and quality strategy. This remote role involves owning the regulatory roadmap across UK, EU, US, and emerging markets, while managing a specialist Compliance & Regulatory team. The ideal candidate will have a strong background in SaMD / AI medical device regulatory affairs, experience navigating evolving regulatory environments, and proven leadership in high-growth situations.