Medical Devices and Regulatory Affairs Researcher / Engineer ISO13485

Blaenau Gwent
12 Jan 2018
11 Feb 2018
Contract Type
Full Time

Medical Devices and Regulatory Affairs Researcher / Engineer (ISO13485)

Bristol / Cardiff

£Neg + benefits

Our client is an innovative medical device company specialising in the design and development of cutting edge electro-mechanical medical devices and they now have an immediate requirement for a Medical Devices Engineer with a minimum one year of experience of medical devices regulatory procedures to provide technical support to the product management team.

The Medical Devices and Regulatory Affairs Researcher / Engineer will provide support for tasks relating to the regulatory approval of the devices:

·Identify potential new devices and compare to current device under development

·Perform literature analysis

·Provide clinical input from literature to risk analysis

·Support regulatory submissions with product and procedure descriptions

·Perform Post Market Surveillance

·Develop instructions for use

·Provide input to training programmes based on instructions for use and risk analysis


·Master degree in a scientific field

·Strong technical understanding

·Extensive experience in literature research

·Experience in medical devices research preferred

·Excellent organisation and prioritisation skills

·Strong interpersonal, written and verbal communication skills

·Excellent knowledge of IT software e.g. Excel, Word, PowerPoint

·Ability to work independently as well as a team member in a fast-paced, time sensitive, constantly changing environment

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