In this role, you will be involved in all phases of the product lifecycle – from early concept and architectural decisions through development, verification, regulatory submission, market release, and sustained lifecycle management. You will combine deep technical understanding with a strong design control discipline, acting as the technical anchor between AI/ML developers, system engineers, quality, regulatory affairs, and project management. * Ensuring compliance with relevant standards and regulations, such as IEC 62304, SaMD, ISO 14971, MDR / FDA requirements, and emerging AI-related guidance and standards (e.g. AI/ML lifecycle management, data management). * Driving lifecycle management activities, including design changes, product updates, NCRs, and CAPAs for marketed systems. Your contact base is broad, and you will collaborate with Ambu's global organization, all departments involved in product ...
mehr