Subject-specific involvement in the implementation of the risk management process, clinical evaluation, and usability file * Control and sole responsibility for reviewing/releasing approval-relevant documents as part of the design control process, in particular Risk analysis/risk management, clinical evaluation, design validation/design verification plans and protocols, software documentation, instructions for use and product labeling * Subject Mater Expert for the interpretation of standard requirements, e.g. for clinical evaluation, biocompatibility, electrical safety, cyber security etc. * Completed studies in the natural sciences, engineering, medical or comparable field * Advanced training “Manager Regulatory Affairs for Medical Devices”
mehr