Tasks performed regularly which form the essential characteristics of the position. - Support for planning and execution of risk management process, the preparation and maintenance of the risk analysis for medical devices in compliance with relevant standards and guidelines - Ensure that all activities regarding risk management are executed according to risk management plan - Participating in Product Development/Design reviews to ensure risks have been properly assessed and addressed - Risk management transfer to production and supporting of production in post transfer risk management activities - Planning and review of risk assessments and transfer of relevant content to risk analysis - Reconciliation of Risk Analysis and Pre-Production Defect Management (Anomaly Reports) - Support in the preparation of FMEAs and anomaly reports - Alignment of the risk analysis with the usability file - Creation of the Overall Risk Evaluation Sheet (with Product Center Manager) - Creation of the Risk Management File or update of an existing Risk Management File - Support, update, and maintenance of the Risk Management File throughout the product lifecycle - Perform or support the risk assessment process within the quality system (i.e. complaints, non-conformances, CAPAs, etc.) - Perform Ad Hoc risk assessments as necessary - Supporting Health Hazard Assessments as required - Perform or support root cause investigation as necessary within the quality system (i.e. complaints, non-conformances, CAPAs, etc.) - Author and/or support the creation and submission of required post market reports (i.e. Periodic Safety Update Reports (PSUR), Clinical Evaluation reports (CERs), etc.) - Monitoring state of the art for continuously improving product safety Tasks performed regularly in addition to the main duties, but which do not determine the essential character of the position. - Support of PMCFs preparation - Project responsibility for compliance projects. - Implementation of new regulatory requirements, coordination of communication with international authorities. - Support in creation of labelling material