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 projects

    • What's on offer:

  • Possible extensions

  • Flexible rate

  • Remote working

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