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.

• Review of customer/application information (IFU, brochure etc.)
• 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