Medical Devices Compliance Specialist

1 month ago


Crawley, West Sussex, United Kingdom Manor Royal Business District Full time
Key Responsibilities

As a Medical Devices Compliance Specialist, you will play a critical role in ensuring compliance with legislation and regulations in the European region. This includes supporting local organizations, creating and maintaining the Regional Submission Process(s) and Regulatory Roadmap for European region, Informing and supporting local organizations regarding changes in legislation, providing interpretation and strategic advice, and representing Elekta in International regulatory bodies.

The ideal candidate will have over 5 years of experience working with regulatory affairs in the European region, with a stronger background in RA than QA expertise. Knowledge and proven track record in Regulatory Affairs for Medical Devices in the European region is essential. Familiarity with the European Directive for Medical Devices and experience with ISO 13485 is preferred.

This exciting opportunity offers an attractive salary range of £70,000 - £90,000 per annum, plus benefits such as up to 30 paid vacation days/year, additional 4 Elekta days off/year (plus bank holidays), Attractive defined contribution pension scheme, Private Medical Insurance, Hybrid work option, Cycle to work scheme, Life Assurance, and Love electric (Electric vehicle salary sacrifice scheme).

We are committed to equal opportunities and welcome applications from talented individuals who share our values.



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