Software Regulatory Affairs Specialist(NHS/Medical Devices) - Surrey, United Kingdom - RedRock Consulting

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