Head of Compliance & Regulation

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, have 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 a strategic differentiator for us, and as AI moves into generative models, care‑continuum agents, and real‑time decision support, Limbic is shaping the next regulatory paradigm for healthcare AI.

The Opportunity

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

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

What You’ll Be Doing at Limbic

• Own Limbic’s global regulatory roadmap across the UK, EU, US and emerging markets, focusing 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 markets
• Own the ComReg department; set goals, objectives, metrics, budget and personal development for the team

Job Details

• Salary: £80,000 + stock options
• Location: UK‑based, remote‑first role with flexibility to align with UK and US hours where required
• Reporting to: Limbic’s General Manager

Essential Requirements

• SaMD / AIaMD experience 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 (e.g., ISO 27001, SOC 2, 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 to work fully remote, from our central London office or in a hybrid setup
• 25 days PTO
• Equity share options
• Quarterly ‘life’ days
• Enhanced parental leave packages
• Access to mental health support

Seniority Level

Executive

Employment Type

Full‑time

Job Function

Legal

Industries

Mental Health Care

Location

London, England, United Kingdom

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