Scipro is seeking an SaMD QARA Manager to lead quality assurance and regulatory compliance for our digital health client of ours based in London. The role focuses on maintaining QMS, ensuring adherence to ISO 13485 and IEC 62304, and managing regulatory submissions (FDA, EU MDR). Join us to shape cutting-edge healthcare innovation Key Responsibilities Maintain and improve QMS for SAMD; support SDLC quality controls; manage risk (ISO 14971); oversee testing/validation protocols. Develop regulatory strategies; prepare submissions (e.g., 510(k), CE Mark); stay updated on regulatory changes; liaise with authorities and notified bodies. Partner with R&D, clinical, and product teams to integrate quality/regulatory needs; train teams on standards and best practices. Enhance QARA processes; monitor/report metrics; support audits, CAPAs, and post-market surveillance. Requirements Bachelor’s in Engineering, Software, or related field; 5 years in SAMD/medical device QARA; strong knowledge of FDA, EU MDR, ISO 13485, ISO 14971, and IEC 62304. Regulatory submissions, risk management, project management, and cross-functional collaboration. RAC/ASQ CQE certification; cybersecurity/GDPR knowledge; agile development experience. Scipro is a recruitment agency acting on behalf of this company. Please apply now or send your CV to l.clelandsciproglobal.com to arrange a confidential conversation.