Bad Homburg, DEU
6 days ago
(Junior) Regulatory Affairs - Devices Specialist (m/f/d)
Important: The position is limited to 18 months. Your Responsibilities: + Defining, maintaining, and continuously improving processes to ensure global regulatory compliance for the approval of FME medical devices + Creation and provision of regulatory documents for the global registration of FME medical devices + Consulting and supporting all involved parties in the global registration of FME medical devices to ensure timely access to all relevant markets + Planning, documenting, monitoring, reporting and tracking of projects in the RIM area + Provision of information on regulatory status (registrations) for all FME medical devices + Implementation and maintenance of a registration information management system (RIMS) including a process to steer and control registration activities worldwide (e.g., workflow-based) in accordance with pre-agreed roadmaps + Support Verticals by creating and provisioning central documents needed for registrations including notarization, apostillation or embassy certifications Your Profile: + Minimum Bachelor in Engineering or Natural Science, Master is desirable but not mandatory + 1-3 years of professional experience in internationally operating companies, including at least 1 year in the medical device industry within regulatory affairs or quality management + Strong stakeholder management and communication skills, while continuously learning and adapting to changing environments + Strong expertise in RA and global regulatory requirements + Strong project management skills, highly structured and systematic working style + Excellent knowledge of FME business and products + Fluent in English, additional language skills (e.g., German) considered a plus + Willingness to travel in the scope of meetings, workshops, conferences, etc. Our offer for you: There is a lot you can discover at Fresenius Medical Care, because we have a lot to offer. No matter on in which field you are an expert (m/f/d) and how much experience you have - for your professional career. A 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
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