Medical Device Risk Manager (m/f/d)
- Troisdorf
To support our Regulatory Affairs Department in Troisdorf, we are in the search of a Medical Device Risk Manager (m/f/d) * Lead overall Risk Management efforts, processes and process improvements for the Varian Proton Solutions business unit in accordance with ISO 14971 * Develop and maintain Risk Management Files for EU class IIb device family that includes risk management plans, hazard analyses and risk assessments * Ensure Risk Management procedures, processes and files are updated where required * Provide Risk Management technical expertise throughout the product life cycle and the organization * Work with cross functional teams on the development and incorporation of Risk Management during all design phases for new and/or product enhancements * Keep up to date on new regulations and standards that affect Risk Management for medical devices.
To support our Regulatory Affairs Department in Troisdorf, we are in the search of a Medical Device Risk Manager (m/f/d) * Lead overall Risk Management efforts, processes and process improvements for the Varian Proton Solutions business unit in accordance with ISO 14971 * Develop and maintain Risk Management Files for EU class IIb device family that includes risk management plans, hazard analyses and risk assessments * Ensure Risk Management procedures, processes and files are updated where required * Provide Risk Management technical expertise throughout the product life cycle and the organization * Work with cross functional teams on the development and incorporation of Risk Management during all design phases for new and/or product enhancements * Keep up to date on new regulations and standards that affect Risk Management for medical devices.
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