8 of 8 Remote ISO 13485 Jobs in the UK

a small company environment Strongly Advantageous: Experience in optoelectronics, PID temperature control, and reliability testing Expertise in IVD/medical device compliance (EU & USA) Experience in regulated product development (ISO 13485, IVDR, 60601, EMC standards, FDA approvals) If you're ready to make a real impact, apply today! How to apply for the role: If you have the More ❯

Comfortable working in a small, fast-paced, and collaborative environment. Proficiency in project management tools (e.g., MS Project, Jira, Confluence, or equivalent). Familiarity with regulated environments (such as ISO 13485) is a plus. Desirable Experience in optical systems,ophthalmic devices, or AR/VR hardware. Project management certification (e.g., PMP, Prince2, Agile/Scrum). Experience balancing More ❯

Comfortable working in a small, fast-paced, and collaborative environment. Proficiency in project management tools (e.g., MS Project, Jira, Confluence, or equivalent). Familiarity with regulated environments (such as ISO 13485) is a plus. Desirable Experience in optical systems,ophthalmic devices, or AR/VR hardware. Project management certification (e.g., PMP, Prince2, Agile/Scrum). Experience balancing More ❯

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 ❯

manufacturing). Proficiency with project management frameworks (Agile, Waterfall) and tools (e.g., MS Project, Jira, Confluence). Excellent client-facing and stakeholder management skills. Familiarity with regulated environments (e.g., ISO 13485, medical device directives) is highly desirable, though not essential. Project management certification (PMP, PRINCE2, Agile/Scrum) would be advantageous. Why Join? This is a career-defining More ❯

manufacturing). Proficiency with project management frameworks (Agile, Waterfall) and tools (e.g., MS Project, Jira, Confluence). Excellent client-facing and stakeholder management skills. Familiarity with regulated environments (e.g., ISO 13485, medical device directives) is highly desirable, though not essential. Project management certification (PMP, PRINCE2, Agile/Scrum) would be advantageous. Why Join? This is a career-defining More ❯

skills Exceptional productivity and efficiency Desirable Requirements Experience with companies who have Artificial Intelligence (AI) as part of their product set Knowledge or experience of medical device regulations including ISO13485 and ISO14971 Knowledge or experience of deploying healthcare technologies in line with DCB0160 best principles Knowledge of wider DTAC competencies (security, data protection, interoperability) Experience in or working with NHS More ❯

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 ❯