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/label + Provide guidance and expertise to help with identification of relevant compliance standards and associated testing + Align change notifications to notified bodies/authorities (with SysQaRa) + Perform conformity assessments (nMD, MD and other Products) + Preparation of technical part for clinical evaluation report + plan + Ensure regulatory product availability on global markets as per in-center commercial strategy + Coordination of regulatory activities, alignment of regulatory strategy and roadmaps across the IC product groups + Compile global registration file (STED) per product and customize/ supplement in preparation of local submission + Preparation of free sale certificates and declarations for regulatory submissions + Registration of medical devices, including trade goods and kits, as well as registration of manufacturing sites and new production lines + Act 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 products + Knowledge 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 basis + Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world + Individual opportunities for self-determined career planning and professional development + A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one + A large number of committed people with a wide range of skills, talents and experience + The benefits of a successful global corporation with the collegial culture of a medium-sized company