1 of 1 Remote ISO 13485 Jobs in London

engineering governance activities, including Critical Design Reviews (CDRs). Collaborate with verification and validation teams to support defect triage and resolution. Monitor regulatory standards, ensuring compliance with IEC 60601, ISO 14971, and other relevant frameworks. Conduct risk management activities, including FMEA, hazard analysis, and early-phase risk reviews. Provide technical input, risk assessments, and continuous improvement recommendations during project … s degree (or equivalent) in Biomedical, Mechanical, Electrical, Systems Engineering, or related discipline. Proven problem-solving skills in high-reliability, life-supporting systems (e.g., ventilators). Demonstrated experience applying ISO 14971 risk management to medical device development as well as IEC 62304 Background in systems engineering disciplines: requirements management, architecture, V&V, and release. Proficiency in requirements engineering and … risk analysis techniques across the device lifecycle. Experience working cross-functionally in multidisciplinary teams. Desirable Skills Experience in R&D within regulated industries, ideally under ISO 13485 and IEC 60601. Knowledge of real-time control systems, control theory, and embedded platforms. Strong collaboration and communication skills, with enthusiasm for advancing medical technologies. If you are interested in the More ❯