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 guidelinesEnsure that all activities regarding risk management are executed according to risk management planParticipating in Product Development/Design reviews to ensure risks have been properly assessed and addressedRisk management transfer to production and supporting of production in post transfer risk management activitiesPlanning and review of risk assessments and transfer of relevant content to risk analysisReconciliation of Risk Analysis and Pre-Production Defect Management (Anomaly Reports)Support in the preparation of FMEAs and anomaly reportsAlignment of the risk analysis with the usability fileCreation of the Overall Risk Evaluation Sheet (with Product Center Manager)Creation of the Risk Management File or update of an existing Risk Management FileSupport, update, and maintenance of the Risk Management File throughout the product lifecyclePerform or support the risk assessment process within the quality system (i.e. complaints, non-conformances, CAPAs, etc.)Perform Ad Hoc risk assessments as necessarySupporting Health Hazard Assessments as requiredPerform 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.

Review of customer/application information (IFU, brochure etc.)Support of PMCFs preparationProject responsibility for compliance projects.Implementation of new regulatory requirements, coordination of communication with international authorities.Support in creation of labelling material