Software QARA Consultant

BI, Big Data & Analytics • London, England • Posted June 21, 2026

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:

  • 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