Software QARA Consultant

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 click apply for full job details