The company is a fast-growing consulting company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Their objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. We help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). They are also authorized representatives for non-EU manufacturers and offer a unique solution for e-labeling, currently used by multi-billion dollar medical device and IVD companies.
From their offices in Geel, Eindhoven, Turin and other international locations the company serves more than 250 customers worldwide.
This is what you will be doing
Due to continuing strategic growth, the company will be looking to expand our Performance Evaluation Studies Departmentover the coming months.
For the role as Performance Evaluation Studies Expert is experience with IVD assay development or validation an advantage. Understanding analytical and clinical performance, including Performance Evaluation Studies, of an IVD assay is a must.
Within the Performance Evaluation Studies department, we design, organize, monitor and document clinical and analytical performance studies for IVD manufacturers in order to support their technical documentation and to ensure the approval by the Notified Bodies. These studies are done in collaboration with European laboratories and blood banks with international recognition and, high standard private labs.
Our tasks include searching, selection and qualification of suitable evaluation centers, drafting evaluation protocols, monitoring the study, data evaluation and analysis and, writing of the evaluation reports.
The role includes, but is not limited to:
This is what you will bring