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, I...
