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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 projects Possible extensions
Flexible rate
Remote working
About the Role
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:
What's on offer:
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