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

Description

Software Regulatory Affairs Specialist(NHS/Medical Devices) - New - Training and ProgressionSalary: £50,000 + Bonus & BenefitsA 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, 27001BS EN IEC 60601BS EN 62304NHS DCB0129 / DCB0160UK General Data Protection RegulationPlease send CV for full job description and an informal chat.

Excellent opportunity to join a market leader growing rapidly in a unique space