Location
Schweinfurt | Germany
Job description
In your role as a Risk Manager (m/f/d) you will be responsible for ensuring product safety for Active Medical Devices, by applying the risk management process throughout the product life cycle.
Your assignments
- Responsible for the 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
- Responsible for the specification of countermeasures (Requirement Management)
- Responsibility for risk management transfer to production
- Responsible for 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 Risk Management File or update of an existing RMM file (with PCM)
- Creation of risk assessments for complaints
- Monitoring state of the art for continuously improving product safety
- Audit support of design & development and risk management sessions
- Creation and monitoring of compliance metrics of design controls in development, change management and Post Market activities
Your profile
- Bachelor’s or master’s degree in engineering or a similar technical field required, such as medical technology or natural sciences
- Experience of minimum 3 years in research and development, regulatory affairs or Risk Management for medical devices or pharmaceuticals
- Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc.)
- Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250, etc.)
- Knowledge of internal and external processes and structures and of the corporate Quality Management requirements
- Knowledge of FMEA methodology and of functional and constructive safety concepts
- Fluent in English in written and spoken, German language is an advantage
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