Head of Compliance Regulation

📋 Description

• • Own Limbic’s global regulatory roadmap across the UK, EU, US and emerging markets, translating the next wave of AI policy into a concrete, time-bound plan that keeps our Class IIa and future devices compliant and competitive.
• • Shape Limbic’s response to evolving regulatory and governmental standards frameworks—whether it is the EU AI Act, FDA’s proposed SaMD guidance, or UK MHRA’s Software as a Medical Device roadmap—turning ambiguity into opportunity and ensuring our products are “regulation-ready” before regulators even finalise the rules.
• • Act as a strategic advisor to product, engineering, commercial and clinical teams on compliant design, deployment, monitoring and evaluation of AI systems, embedding quality, safety and post-market surveillance requirements into every sprint and roadmap decision.
• • Build and nurture relationships with auditors, regulators, policy makers and ecosystem partners (notified bodies, standards bodies, academic consortia) to maintain Limbic’s position as a global regulatory thought-leader, opening doors for faster approvals, co-authored guidance and policy influence.
• • Manage and develop a small but high-impact Regulatory Affairs and Information Security team—setting clear goals, objectives, metrics and budgets—while mentoring specialists so they can operate autonomously and scale with the company.
• • Guide the information-security strategy to maintain and strengthen Limbic’s security posture as we scale across more customers and more markets, ensuring ISO 27001, SOC 2, HIPAA and GDPR compliance without creating friction for engineering or clinical teams.
• • Personally steer the most complex regulatory workstreams—especially pre-submission packages, technical documentation, risk management files and post-market clinical follow-up—acting as the accountable owner who can dive deep into SaMD dossiers when the stakes are highest.
• • Own the ComReg department’s OKRs, quarterly business reviews and board-level reporting, translating regulatory milestones into commercial impact (faster procurement, larger contracts, higher win-rates) and measurable patient outcomes.
• • Champion a culture of “compliance by design” across Limbic, running internal training, brown-bags and design reviews so that every engineer, PM and clinician understands how regulatory excellence accelerates innovation rather than slows it down.
• • Continuously scan the horizon for emerging risks—generative AI bias, federated learning governance, real-time agent autonomy—and prototype mitigation strategies that can be stress-tested with regulators before they become compliance blockers.