Job description
Software as Medical Device QARA Consultant (3-6 Month Contract, Remote) We're seeking an experienced QARA Consultant to 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 62304/82304/62366 Confident leading submissions, client engagements, and multiple …