Expert knowledge and experience in medical writing (literature as well as vigilance search, evaluation and review; database management) is required - Insufflators, pumps and disposable tube sets, along with medical visualization and operating room integration technologies are the preferred solution for minimally invasive surgery applications. The Medical Affairs (Clinical Affairs) Manager is held responsible for keeping a product or product group compliant with regulations and guidelines. The employee ensures the proper implementation of procedures that demonstrate the conformity of medical devices with the relevant clinical performance and safety requirements as well as the documentation required by MDR/MEDDEV. * Focusing on Medical Affairs related processes such as PMS, PMCF, Clinical Evaluation, Risk Management, Change Management and Nonconformance/Corrective and ...
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