Software QARA Consultant
Posted 1 day ago by Computer Futures
£100 Per hour
Undetermined
Remote
London
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 and support the implementation of Quality Management Systems (QMS). The position is remote and offers flexibility in terms of contract duration and rate. Candidates should have proven experience with regulatory submissions and a strong understanding of relevant standards.
Key Responsibilities:
- Manage end-to-end regulatory submissions for CE and FDA approvals.
- Support the implementation of Quality Management Systems (QMS).
- Lead client engagements and multiple projects.
- Ensure compliance with ISO 13485, ISO 14971, IEC 62304/82304/62366 standards.
Key Skills:
- Proven experience with CE marked and FDA-authorised SaMD/AIaMD products.
- Strong knowledge of ISO 13485, ISO 14971, IEC 62304/82304/62366.
- Confident in leading submissions and client engagements.
- Ability to manage multiple projects effectively.
Salary (Rate): £100/hour
City: London
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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 (url removed)
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 | OC(phone number removed) England and Wales