Risk Management Expert

1 settimana fa

Palazzo Pignano, Italia Fresenius Medical Care A tempo pieno

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

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