Head of Compliance & Regulation

Entrepreneur First; Greater London; Hybrid; GBP 80,000; Full time

Job summary

A leading AI healthcare company in London seeks a Head of Compliance & Regulation to manage regulatory strategy and ensure compliance with evolving standards across the UK and US. This hybrid role combines leadership with active responsibility over regulatory affairs. The ideal candidate will have strong SaMD/AIaMD experience, navigate complex regulatory environments, and integrate compliance in product development. The role offers a competitive salary of £80,000 plus stock options and allows flexibility in work arrangements.

Benefits

25 days PTO

Equity share options

Quarterly ‘life’ days

Enhanced parental leave packages

Access to mental health support

Qualifications

• Proven experience in software regulatory affairs.
• Strong experience with ambiguous regulatory environments.
• High-performance management of cross-functional teams.

Responsibilities

• Own the global regulatory roadmap.
• Shape responses to governmental standards.
• Advise teams on compliant AI system design.
• Build relationships with regulators and partners.
• Manage and develop regulatory compliance specialists.
• Direct the infosec strategy for scaling.
• Oversee the goals and metrics of the ComReg department.

Skills

SaMD / AIaMD experience

Ability to navigate ambiguous regulatory territory

Strategic thinking and hands-on execution

Exceptional organisational skills

Decision-making in complex regulatory scenarios

Integration of regulatory requirements in design

Tools

ISO 27001

SOC2

HIPAA

Job description

Location

UK

Employment Type

Full time

Location Type

Hybrid

Department

ComReg

About Limbic:

Limbic is the leading clinical AI company for mental healthcare and the largest deployment of patient‑facing mental health AI in the world. Our technology has supported over half a million patients across the UK and US, helping health systems deliver higher‑quality, more accessible, and more efficient care.

We regulated the first AI diagnostic model for adult mental health as a Class IIa medical device. We’ve published in top‑tier journals, won major awards, and advise governments and regulators globally on AI safety, medical devices, and the future of clinical agentic systems.

Regulation is not a cost centre at Limbic, it is a strategic differentiator. As AI moves into an era of generative models, care‑continuum agents, and real‑time decision support, Limbic is shaping what the next regulatory paradigm for healthcare AI will look like.

This role is for someone who wants to be at the forefront of that shift.

The Opportunity:

As Head of Compliance & Regulation, you will lead the team responsible for all things medical device regulation, quality management and information security. You’ll partner closely with senior leadership to set the regulatory strategy that positions Limbic ahead of global AI policy changes, particularly the emerging frameworks in the US, UK and Europe.

This is a hybrid role: part strategic leader, part hands‑on operator. You will manage a small but high‑impact team, while also personally steering our most complex regulatory work - especially across medical device strategy and the next generation of AI regulatory pathways.

What You’ll be Doing at Limbic:

• Own Limbic’s global regulatory roadmap across the UK, EU, US and emerging markets, with a focus on next‑generation AI/ML, LLM‑based and agentic medical devices

• Shape Limbic’s response to evolving regulatory and governmental standards/frameworks

• Act as a strategic advisor to product, engineering, commercial and clinical teams on compliant design, deployment, monitoring and evaluation of AI systems

• Build relationships with auditors, regulators, policy makers and ecosystem partners to maintain Limbic’s position as a global regulatory leader

• Manage and develop RA and infosec specialists; ensure the team is empowered, high‑performing, and working on the right things

• Guide the infosec strategy to maintain and strengthen Limbic’s security positioning as we scale across more customers and more markets

• Own the ComReg department; goals, objectives, metrics, budget and personal development

Job Details:

• Salary = £80,000 + stock options

• UK‑based, remote‑first role but requires flexibility to align over UK and US hours where required

• Reporting into Limbic’s General Manager

Essential Requirements:

• SaMD / AIaMD experience. Whilst this role oversees our full ComReg department (both medical device/RA and infosec), we’re looking for someone with a background in software regulatory affairs as core domain expertise

• Experience navigating ambiguous or emerging regulatory territory

• Demonstrated ability to operate as both a strategic thinker and hands‑on IC in a fast‑moving environment

• Exceptional organisational skills with the ability to prioritise, structure, and execute cross‑functional work

• Comfortable making decisions in complex or uncertain regulatory scenarios with incomplete precedent

• Evidence of partnering with product/engineering teams to integrate regulatory requirements earlier in design

Non‑Essential Requirements:

• Experience with information security frameworks (eg. ISO 27001, SOC2, HIPAA)

• Direct exposure to generative AI, model evaluation, or agent‑based systems

• Experience working in a startup or high‑growth scale‑up

• Experience engaging directly with regulators, notified bodies or auditors

What We Offer:

• Flexibility regarding fully remote, from our central London office or hybrid

• 25 days PTO

• Equity share options

• Quarterly ‘life’ days

• Enhanced parental leave packages

• Access to mental health support