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 projectsWhat's on offer:
Possible extensions
Flexible rate
Remote working
Please click to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.
To find out more about Computer Futures please visit...
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 projectsWhat's on offer:
Possible extensions
Flexible rate
Remote working
Please click to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.
To find out more about Computer Futures please visit...