Clinical Evaluation Specialist

The Clinical Evaluation Specialist in the Medical Affairs team plays the lead role in the planning, creation, update of Clinical Evaluation Reports Clinical Benefit-Risk Assessments, Clinical Evaluation Reports and associated documentation (PMCF plans, PMCF reports, SSCP’s)

What you will do:

The Clinical Evaluation Specialist acts as the lead technical expert in driving this highly complex and demanding process. He/she applies scientific, regulatory and project management skills to establish the evaluation strategy and to compile the body of Clinical Evidence, allowing, in collaboration with the Medical Expert, to reach a legally binding scientific conclusion on the safety and performance of devices in patients, throughout the product lifecycle.

The Clinical Evaluation Specialist bears the operational and regulatory responsibility of individual clinical evaluation reports and may defend them in audit situations.

Tasks include