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In-Vitro Diagnostics Devices Quality Lead

In-Vitro Diagnostics Devices Quality Lead

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In-Vitro Diagnostics Devices Quality Lead

MSI Pharma is partnering with a global biopharmaceutical company and one of the world leaders in cutting-edge scientific research, on an IVD Devices Quality Lead role on an initial 12 month contract.

This is a collaborative role, assisting in the selection and follow-up of partners, devices and laboratories, that will perform the tests in the framework of clinical studies; whilst working with various stakeholders based in the US and UK.

The ideal candidate will be comfortable analysing and solving complex problems in an ever evolving regulatory field), whilst displaying the ability to collaborate with both internal and external stakeholders, ensuring active listening throughout the process.

Additional Job Duties:

  • Define requirements in partnership with regulatory affairs.
  • Lead or support implementation of quality process improvement and maintain applicable QMS sections to ensure consistency and compliance to EU IVDR, US FDA and other territories.
  • Clinical study support for laboratories conducting clinical studies.

Required Skills and Experience:

  • Good knowledge of regulations, standards and guidance applicable to IVD products
  • Education: Master's degree in a relevant discipline or a Bachelor's degree with relevant work experience
  • Experience: 2 to 5 years of experience in Quality OR Clinicals studies of IVD's or Medical Devices.

Start date: ASAP

Location: Braine-l'Alleud, Belgium (Hybrid Working)

Full job specification(s) available upon request.

If you are interested, then please apply now! If you would like more information, then kindly drop me an email or give me a call.