2 of 2 Remote/Hybrid Contract QMS Jobs

/recommendations. Provide SME advice on compliance queries; assess impacts and support closure of actions. Support governance meetings Maintain audit trail/records, follow QMS and agreed communication routes (technical via Technical Contact; commercial via Commercial Contact); support briefings/knowledge transfer as required. Key deliverables Legislation register maintained ...

work on multiple SaMD and AIaMD project on quality and regulatory activities. You'll own end-to-end regulatory submissions (CE & FDA), support QMS implementation. Key requirements: Proven experience with CE marked & FDA-authorised SaMD/AIaMD products Strong knowledge of ISO 13485, ISO 14971, IEC 62304/82304/ ...