1 ISO 13485 Jobs in Surrey

Position : Medical Device Regulatory Specialist Suitable for : Regulatory Affairs Specialist with strong experience of ISO 13485 and MDD and MDR Location : Hybrid, ideally Surrey based, with the expectation to travel to Milton Keynes and Surrey sites if required (approx. once a month) + client travel as and when … require experience in the context of Software as a Medical Device (SaMD) to qualify for this position, as well as an essential requirement of ISO 13485 and DCB0129. Essential: • Min 3 years’ experience as Medical Device Regulatory Specialist, Regulatory Affairs Specialist with medical device experience • Good working experience … Medical Device Directive/Medical Device Regulation transition process. • Up-to-date working knowledge of: MDD and MDR (Class 1 & 11a devices) BS EN ISO 13485, 14971, 14155, 27001 BS EN IEC 60601 BS EN 62304 NHS DCB0129/DCB0160 UK General Data Protection Regulation • Good working knowledge more »