In-Vitro Diagnostics Devices Quality Lead

Updated: March 03, 2024 09:38 AM GMT

Full time Job in Meise, Flanders

MSI Pharma

Braine-l'Alleud, Belgique

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... More Detail