4 of 4 Remote/Hybrid ISO 13485 Jobs in the UK

patient safety principles An appreciation of electronics and hardware integration, beneficial rather than essential Familiarity with medical device standards and regulated pathways, for example ISO 13485, IEC 62304, ISO 14971, IEC 60601 and IEC 62366 Just as important as the person This is the part that will ...

similar tools. Working within regulated, compliance-driven environments. Highly Desirable Healthcare software experience. Medical device software experience. Software as a Medical Device (SaMD). ISO 13485 exposure. IEC 62304 exposure. Validation and verification (V&V) activities. Audit-ready documentation and traceability management. ...

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 ...

devices or another regulated industry (e.g. aerospace, automotive safety, or similar safety-critical sectors) Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304, IEC 60601, or equivalent A strong grasp of the documentation, traceability, and verification rigour required for regulated, safety-critical software ...