26 to 28 of 28 ISO 13485 Jobs in the UK

supporting clinical trials and ensuring compliance with international standards. Key Responsibilities Define and document system architecture, design inputs, and interfaces. Lead risk management activities (FMEA, FTA) in compliance with ISO 14971. Maintain technical documentation (DHF) for audits and regulatory submissions. Manage system and sub-system requirements with full traceability. Support clinical investigations and verification testing. Collaborate with cross-functional … and regulatory. Drive process improvements and stay current with evolving standards. Skills & Experience Essential: Degree in engineering or a related field. Experience in regulated medical device development. Familiarity with ISO 14971 & ISO 13485. Strong understanding of system-level requirements and V&V principles. Desirable: Experience with implantable or active medical devices. Knowledge of IEC 60601, IEC 62304, or … ISO 14708. Proficiency with document control and requirements management tools. Experience working with clinical and academic partners. Whats on Offer Competitive salary based on experience. Private healthcare, income protection, life assurance. Company pension scheme. 27 days holiday plus bank holidays. Hybrid working. The opportunity to contribute to a transformative medical technology platform. More ❯

excellent benefits. Location: Cardiff Software Design Manager Responsibilities: Carry out engineering activities in accordance with company QA procedures and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and appropriate standards including IEC 60601, IEC 62304, ISO 14971. Management of resources providing motivation, supervision and guidance of software engineering staff. Ensure adherence to More ❯

excellent benefits. Location: Cardiff Software Design Manager Responsibilities: Carry out engineering activities in accordance with company QA procedures and to meet regulatory regimes such as Medical Device Regulation (EU), ISO13485 (Int), FDA CFR820 (USA) and appropriate standards including IEC 60601, IEC 62304, ISO 14971. Management of resources providing motivation, supervision and guidance of software engineering staff. Ensure adherence to More ❯