Your Responsibilities Lead Risk Management efforts and processes, as well as process improvements for the entire Qmedics portfolio. Ensure the comprehensive implementation and maintenance of the Risk Management procedure in accordance with ISO 14971, ISO 13485, and the Medical Device Regulation. Develop and maintain Risk Management Files for an EU class IIa, IIb and III device family that includes risk management plans, hazard analyses and (clinical) risk assessments. Signal detection and benefit/risk evaluation, including initiating appropriate measures e.g., prepare safety review presentations, update the risk documentation and resulting action plans, initiate IFU changes etc. Implement documentation necessary for Vigilance, such as Risk Management plans, and support the timely issuance of inter-departmental reports, e.g., clinical evaluation reports. Keep abreast of changes to regulations and standards as they impact on risk management. Support the review and improvement of the QMS to ensure it is in line with the MDR. Provide inputs to post-market / vigilance processes. Participate in audit session: planning and documentary preparation, assistance during audit, support to action plan definition and implementation.