Senior Regulatory Affairs Specialist with Environmental
Posted 4 days ago by Selexa Consulting Ltd
Selexa Biotech are exclusively partnered with a leading Medical Device manufacturer near Gloucestershire as we continue to develop and grow the QARA function.
A leader in medical device innovation and technology advancement within perfusion and Medical Device software for improved patient outcome.
The Senior RA Specialist role will be supporting a number of NPI projects, taking accountability and ownership of our clients Regulatory submissions, processes, complaints and driving QARA standards across the business…
- Responsible for improving and implementing QMS improvements and amendments
- Hands-on working knowledge of FDA/MHRA regulations and working with the appropriate notified bodies
- You will be the expert within FDA approvals; proven experience and fully conversant in FDA regulations and requirements for approvals
- Further experience of UKCA and CE marking, working cross functionally throughout the business to ensure the highest possible conformance
- Prior experience of completing 510k submissions
- Proficient working knowledge across ISO13485, ISO14971, SaMD, IS14001 – experience of creating, delivering and implementing an environmental management system is beneficial
Get in touch to discuss this excellent opportunity with a leading innovator...
- Type:
- Permanent
- Contract Length:
- N/A
- Contact Name:
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- Telephone:
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- Job Reference:
- LBSRA
- Job ID:
- 221893456
- Applications:
- Be first to apply
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