Your responsibilities:

Creation, maintenance, appoval and control of global regulatory product documentation (e.g. global technical documentation, registration files)Content creation, alignment and approval of instruction of use/SM/IGL/labelProvide guidance and expertise to help with identification of relevant compliance standards and associated testingAlign change notifications to notified bodies/authorities (with SysQaRa)Perform conformity assessments (nMD, MD and other Products)Preparation of technical part for clinical evaluation report + planEnsure regulatory product availability on global markets as per in-center commercial strategyCoordination of regulatory activities, alignment of regulatory strategy and roadmaps across the IC product groupsCompile global registration file (STED) per product and customize/ supplement in preparation of local submissionPreparation of free sale certificates and declarations for regulatory submissionsRegistration of medical devices, including trade goods and kits, as well as registration of manufacturing sites and new production linesAct as regulatory change project lead

Your profile:

Technical/engineering /scientific background (degree)Minimum of 1 year professional experience in the field of regulatory or quality assurance medical devices / medical productsKnowledge in the field of development and/or manufacture and control of medical devices and medical products (2 years)Required: Office (Excel/Word/Power Point), additional: QTRAK, PDM systems as PTC Windchill, FMEA tools

Our offer for you:

There is a lot you can discover at Fresenius Medical Care, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:

The option to work on a mobile basisWhether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the worldIndividual opportunities for self-determined career planning and professional developmentA corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest oneA large number of committed people with a wide range of skills, talents and experienceThe benefits of a successful global corporation with the collegial culture of a medium-sized company