Senior Regulatory Affairs Manager, SaMD & GxP, United Kingdom We are looking for a Senior Regulatory Affairs Specialist to support the regulatory strategy and compliance activities for AI-enabled software products used within clinical and healthcare environments. This position will play a key role in ensuring products meet international regulatory and quality standards across the UK, EU and US markets. The role will involve leading regulatory submissions and maintaining compliance for Software as a Medical Device (SaMD) and AI-based technologies, while working closely with cross-functional teams including Quality, Engineering, Product, Clinical Operations and Data Science. You will provide regulatory guidance throughout the software development lifecycle, including validation activities and risk management processes. Key responsibilities include: Developing and implementing regulatory strategies for software and AI-driven medical technologiesSupporting global regulatory submissions and interactions with notified bodies, auditors and regulatory authoritiesEnsuring compliance with relevant standards and regulations including ISO 13485, IEC 62304, ISO 14971 and AI/ML guidanceReviewing technical documentation, risk management files and validation documentationSupporting audits, inspections and quality management activitiesMonitoring regulatory developments and advising internal teams on compliance requirements The ideal candidate will have: Significant experience within Regulatory Affairs focused on SaMD and AI-based healthcare technologiesStrong knowledge of global medical device regulations and quality standardsExperience supporting software validation and regulated development environmentsExcellent stakeholder management and cross-functional communication skillsA degree in a scientific, engineering or technical discipline If you are interested in finding out more, click apply now!

SciPro is partnered with a venture-backed HealthTech company leveraging AI to transform how hospitals operate under value-based care models. The company is building enterprise-grade, AI-powered infrastructure that enables health systems to better manage clinical workflows, improve patient outcomes, and optimize reimbursement in an increasingly complex regulatory environment. With major federal policy shifts, most notably the CMS TEAM (Transforming Episode Accountability Model), driving urgent demand, this organization is uniquely positioned to become a category-defining platform in value-based care enablement. This is a high-impact, revenue-driving leadership opportunity to shape go-to-market strategy and close complex enterprise deals with leading U.S. health systems during a critical period of market adoption. Responsibilities Own the full sales lifecycle, build and manage a robust pipeline from outbound prospecting through deal closeDrive new logo acquisition across health systems, hospitals, and provider groupsLead complex enterprise sales processes, including RFPs, contract negotiation, and executive alignmentBuild and maintain relationships with C-suite stakeholders (CEO, CFO, CIO) and clinical leadershipIdentify and develop strategic partnerships with health systems and healthcare organizationsAct as a market expert on value-based care, CMS programs, and evolving reimbursement modelsTranslate clinical and financial value propositions into compelling, ROI-driven narratives for buyersCollaborate cross-functionally with Product, Marketing, and Customer Success to align GTM strategyProvide market feedback to inform product roadmap and positioningMaintain accurate pipeline forecasting and performance tracking in CRM systems (e.g., HubSpot, Salesforce)Report on key business development metrics including pipeline health, win rates, and sales cycle efficiency  Qualifications 6–10+ years of enterprise business development, sales, or strategic partnerships experienceAt least 3+ years selling into health systems, IDNs, or large provider organizationsProven track record of closing complex, multi-stakeholder enterprise deals in the $500K–$2M+ ACV rangeDeep understanding of health system dynamics, including:Electronic health record ecosystems (Epic, Cerner)Value-based care modelsCare coordination and clinical workflowsExperience navigating long enterprise sales cycles, including RFP processes, procurement, legal review, and executive sign-offStrong executive presence with the ability to engage and influence senior stakeholdersData-driven approach to pipeline management, forecasting, and performance trackingAbility to operate both strategically and tactically in a fast-paced, early-stage environmentBachelor’s degree required; advanced degree (MBA, MHA, MPH) is a plus  Nice to Have Experience with value-based care, population health, or CMS quality programs (HEDIS, Stars, MIPS)Background in health IT implementation or clinical informaticsPrior experience in Seed to Series B startup environmentsExisting network of health system executives or healthcare decision-makersExperience building or managing channel and partnership relationships