Description
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Risk Manager for Medical Products (m/f)
Referenz: -en
Beginn: asap
Dauer: 6 MM
Ort: in Hamburg
Branche: Herstellung von Bestrahlungs- und Elektrotherapiegeräten und elektromedizinischen Geräten
Ihre Aufgaben:
- Responsibility for Product Risk Management Files (RMF) of DXR systems
- Documentation of the risks in the RMF
- Conducting and leading meetings with experts to assess and document product risks
- Support of the generation of Post Market Risk Assessments (assessment of risks of products that are already in the field)
- Conducting and documenting Health Hazard Evaluations and Risk Benefit Analyses
- Design and implementation of risk management process improvements
- Responsible that the created risk management documents are fulfilling existing norms and compliance requirements
- The risk manager is working with or in a system project team for product development, he is covering all aspects of product risk management
Ihre Qualifikation
- Science degree or comparable educational background
- Broad experience and knowledge in product risk management and process, preferable in medical industry and/or X-Ray Systems
- Knowledge of relevant standards, e.g. ISO 14971
- Fluent in spoken and written English and German
- Experience in conducting risk management teams
Skills:
- Quality manager
- Quality assurance professional
- Regulatory affairs manager