Software QARA Consultant
Posted 1 day ago by Totaljobs
£100 Per hour
Undetermined
Remote
London; City of London; East London; Central London; South East London; West London; Canary Wharf; South West London; North London; Greenwich; Stratford
Summary: The role of Software as Medical Device QARA Consultant involves overseeing quality and regulatory activities for various SaMD and AIaMD projects. The consultant will be responsible for end-to-end regulatory submissions to CE and FDA, as well as supporting the implementation of Quality Management Systems (QMS). The position is remote and offers flexibility in terms of rate and potential contract extensions.
Key Responsibilities:
- Manage end-to-end regulatory submissions for CE and FDA.
- Support the implementation of Quality Management Systems (QMS).
- Lead client engagements and multiple projects.
- Ensure compliance with regulatory standards for SaMD and AIaMD products.
Key Skills:
- Proven experience with CE marked and FDA-authorised SaMD/AIaMD products.
- Strong knowledge of ISO 13485, ISO 14971, IEC 62304/82304/62366.
- Confidence in leading submissions and client engagements.
- Ability to manage multiple projects simultaneously.
Salary (Rate): £100 per 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.
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