Head of Regulatory Affairs

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

Job summary

A high-growth healthcare Digital Health company in Liverpool is hiring a Head Regulatory to lead global regulatory and quality strategy. You will own the regulatory roadmap across multiple markets while managing a specialist team. The ideal candidate has a strong background in SaMD regulatory affairs and experience in fast-evolving settings. This role is remote, offering the opportunity to influence compliance during rapid growth.

Qualifications

• Strong background in SaMD / AI medical device regulatory affairs.
• Experience in ambiguous or fast-evolving regulatory environments.
• Proven ability to work strategically 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 ensure compliance.

Skills

SaMD / AI medical device regulatory affairs

Operating in fast-evolving environments

Cross-functional leadership

Strategic thinking

Hands-on execution

Job description

Head Regulatory

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

Essential Experience

• 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.