Regulatory Affairs Expert, Digital Software Products (m/f/d)

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