Software QARA Consultant

Summary: The role of Software as Medical Device QARA Consultant involves overseeing quality and regulatory activities for multiple SaMD and AIaMD projects. The consultant will manage end-to-end regulatory submissions for CE and FDA approvals while supporting the implementation of Quality Management Systems (QMS). This position is remote and offers potential contract extensions. The ideal candidate will have proven experience in the field and strong knowledge of relevant standards.

Key Responsibilities:

• Manage end-to-end regulatory submissions (CE & FDA) for SaMD and AIaMD projects
• Support the implementation of Quality Management Systems (QMS)
• Lead client engagements and multiple projects

Key Skills:

• Proven experience with CE marked & FDA-authorised SaMD/AIaMD products
• Strong knowledge of ISO 13485, ISO 14971, IEC 62304/82304/62366
• Confident leading submissions and client engagements

Salary (Rate): £100 per hour

City: London

Country: United Kingdom

Working Arrangements: remote

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

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

Please click here 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 www.computerfutures.com

Computer Futures, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office | 8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales