Risk Manager for active medical devices (m/f/d), Schweinfurt

Mehr als 250.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

Your challenge in detail

• Planning, organising and drafting risk management activities such as risk analyses and assessments in development projects for active medical devices
• Responsibility for product risk management regarding patient and user safety
• Analysis and assessment of international regulatory requirements for product risk management (CE, MDR EU, FDA etc.)
• Participating in the further development of standards for the planning and drafting of risk analyses applying to all products
• Definition, implementation, training and continuous improvement of the product risk management processes
• As Risk Manager, you will be acting as an interface and contact person within the company and collaborating closely with the various R&D teams and the responsible persons for the product groups
• Exchange of views on all active medical device requirements (SOPs, standards, directives etc.) within the risk management community across different locations

Your desired competences

• Technical degree, e.g. in the field of medical engineering, engineering science, computer science or physics
  
• At least 3 years’ professional experience in the research & development of complex technical systems (medical devices, aerospace technology, defence, automotive, chemical or pharmaceutical etc.)
• Ability to moderate working groups and expert panels as part of risk management
• Experience in conducting risk analyses for active medical devices as well as knowledge of the regulatory environment of medical devices are desirable
• Excellent analytical and decision-making skills
• Independent and results-oriented approach to work
• Good knowledge of English (C1) and German (B2)
• Willingness to travel occasionally to domestic and international locations