Job Title

Head Regulatory AI / Software as a Medical Device (SaMD)UK-based | RemoteA 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 RoleYou’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 ResponsibilitiesLead global medical device regulatory strategy for SaMD / AIaMDNavigate evolving and emerging AI regulatory frameworksPartner with product and engineering teams to embed compliance into design and deliveryOwn relationships with regulators, auditors, and notified bodiesLead information security strategy as the business scalesManage and develop a specialist Compliance & Regulatory teamEssential ExperienceStrong background in SaMD / AI medical device regulatory affairsExperience operating in ambiguous or fast-evolving regulatory environmentsAble to work strategically and hands-on in a high-growth settingProven cross-functional leadership with product and engineering teamsStartup or scale-up experienceInterested or know someone suitable?Apply directly or message for a confidential discussion.