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Job Description
Software Regulatory Affairs Specialist(NHS/Medical Devices) - New - Training and Progression!
Salary: £50,000 + Bonus & Benefits
A leading software house in the healthcare space requires a Software based Regulatory Affairs Specialist(NHS/Medical Devices) to join its fast growing team.
Suitable candidates will have:
- Technical background within medical devices with an in-depth understanding of the regulatory function, with good knowledge of related quality, engineering, clinical, safety, and post-market functions.
- Experience working in Regulatory Affairs within software.
- 3+ years regulatory affairs experience within the medical device sector.
- Good working knowledge of EN 62304, having maintained electronic and software devices technical files.
- Experience in the production and maintenance of documentation supporting NHS DCB0129/0160.
- Willingness and ability to write and update regulatory and technical documentation and complete the required regulatory submissions.
- Strong understanding of Medical Device Directive / Medical Device Regulation transition process.
Up-to-date working knowledge of:
- MDD and MDR (Class 1 & 11a devices)
- BS EN ISO 13485, 14971, 14155, 27001
- BS EN IEC 60601
- BS EN 62304
- NHS DCB0129 / DCB0160
- UK General Data Protection Regulation
Please send CV for full job description and an informal chat. Excellent opportunity to join a market leader growing rapidly in a unique space!