Software Medical Devices Analyst/Consultant - New Role

Full Job Description

Software Medical Devices Analyst/Consultant - New Role

Up to £50k + Home based + Excellent Benefits + Bonus

A leading organisation within the healthcare sector requires a Software Medical Devices Analyst / Consultant to join its growing team and contribute to the improved effectiveness of community-based care.

The concentration of the role is the production of software medical device technical documentation in compliance with the Medical Device Regulation and ISO 13485 (Medical Devices). Some input will also be required to support ongoing compliance with other ISO standards.

Suitable candidates will have he following skills/experience:

• Technical background within software medical devices with a strong understanding of the regulatory function, and a good knowledge of related quality, engineering, clinical, safety, and post-market functions.
• Circa 3 years experience within the software medical device sector.
• Strong understanding of Medical Device Directive / Medical Device Regulation transition process.
• Up to-date working knowledge of the following: MDD and MDR (Class 1 & 11a devices); BS EN ISO 13485, 14971, 14155, 2700; BS EN IEC 606; BS EN 62304; NHS DCB0129 / DCB0160

Additionally, you will have the following:

• 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.
• Excellent verbal and written English and have reporting and presentation skills.