Global Regulatory Affairs Officer - Medical Device Software

Kirkham Young Ltd
10 Aug 2017
15 Aug 2017
Contract Type
Global Regulatory Affairs Officer - Medical Software

This successful international company specialises in the development and manufacture of fully integrated analyzer systems, software and sample preparation equipment for the life science and medical diagnostic industry. It provides complete system solutions to leading pathology laboratories, blood banks and research institutes around the world.

Due to significant growth, it now has a position for a Global Regulatory Affairs Officer to take charge of maintaining current product registrations as well as defining and implementing the regulatory strategy for newly developed products.
To apply you will need at least three years' experience and a strong regulatory background working with class 2 medical devices and MHRA regulations (essential). You will have a strong IT background, with experience of 510K premarket submissions and compliance aspects of software projects within an ISO13485 environment.
In return for your skills and experience you will receive a competitive salary and package along with the opportunity to join this expanding and successful life science company.

Staffordshire, Burton upon Trent, Derby, Tamworth, Stafford, Uttoxeter, Ashby de la Zouch, Nottingham