Regulatory Engineer- Medical Devices

4 weeks ago


United Kingdom Xstrahl Limited Full time

Xstrahl is a leading medical technology company that designs and manufactures Medical X-ray Systems used in treatment of cancers and dermatological disorders, as well as a pioneer in the development of advanced X-ray systems for pre-clinical radiation biology research.
We are looking for a QARA Engineer who can work as part of the R&D team and support the team on design controls activities ensuring that the product development activities are in compliance with Xstrahl's Quality Management System's requirements..
The role will also support product regulatory submissions, product design transfer activities, CAPA analysis, and field corrections.
Minimum Bachelor's Degree in Software Engineering, Computer Science, Electrical Engineering or any other engineering discipline
Minimum 3 years of experience in quality engineering role in medical device industry
Working knowledge of Medical Products Quality Management System
Experience in creating documentation for regulatory compliance (for example: Experience in regulatory requirements of countries beyond US and EU
Working knowledge with medical radiation products
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