Quality Assurance and Regulatory Affairs Professional

24 hours ago


Crawley, West Sussex, United Kingdom Elekta Full time

Elekta is seeking a Senior Quality Assurance Engineer to join our team in the United Kingdom or Sweden. As a key member of our quality assurance team, you will be responsible for promoting and ensuring compliance to the quality management system and regulatory requirements.

The successful candidate will have experience and training in regulatory affairs and/or in quality management systems and/or Engineering within a medical device environment. A university degree in Engineering or equivalent in a related field is required. Additionally, experience from design and development and risk management, preferably including experience from projects involving medical device software, is highly desirable.

We offer a competitive salary of £70,000 - £90,000 per year, depending on experience, plus a range of benefits including up to 25 paid vacation days (plus bank holidays), a holiday purchase scheme, private medical insurance, and an attractive employer pension contribution package. We also offer a hybrid work option with a minimum requirement of three days per week working on location.

In this role, you will be responsible for representing the Quality function in decision forums, projects, and processes, collaborating closely and communicating effectively with other functional areas of the organization to meet business objectives ensuring regulatory compliance. You will participate in preparation and supporting external audits by coaching others, and/or as guide and/or auditee, and participate in preparation and performing internal quality audits.



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