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!

A fast-growing, venture-backed healthtech company is seeking a Senior Implementation Engineer to help build and scale integrations across hospital and clinical systems. The company is developing AI-powered infrastructure focused on helping health systems improve operational performance, care coordination, compliance, and reimbursement outcomes in the evolving value-based care landscape.This is a highly cross-functional role at the intersection of healthcare interoperability, technical implementation, and customer-facing delivery. The ideal candidate has experience working directly with hospital IT teams and leading complex EHR integrations across clinical environments. What You’ll Be Doing:• Lead technical implementations and integrations with major EHR platforms and healthcare systems• Partner directly with hospital IT, clinical informatics, and operational stakeholders during deployments• Design and support integrations leveraging interoperability standards such as FHIR APIs and HL7 v2• Troubleshoot interface and data flow issues across production and testing environments• Collaborate closely with product and engineering teams to improve integration architecture and implementation processes• Help define scalable implementation playbooks and best practices as the organization grows Your Experience:• 4+ years of experience in healthcare IT, interoperability, implementation engineering, or related areas• Hands-on experience working with EHR/EMR systems and healthcare integrations• Strong understanding of FHIR and/or HL7 standards• Experience working directly with hospital or health system stakeholders• Ability to manage complex technical implementations in fast-paced environments• Experience integrating with platforms such as Epic, Cerner/Oracle Health, Meditech, or Athenahealth• Familiarity with interoperability or interface tools such as Mirth, Cloverleaf, Rhapsody, or similar technologies