(Junior) Regulatory Affairs - Devices Specialist (m/f/d)
Fresenius Medical Care
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 devicesCreation and provision of regulatory documents for the global registration of FME medical devicesConsulting and supporting all involved parties in the global registration of FME medical devices to ensure timely access to all relevant marketsPlanning, documenting, monitoring, reporting and tracking of projects in the RIM areaProvision of information on regulatory status (registrations) for all FME medical devicesImplementation 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 roadmapsSupport Verticals by creating and provisioning central documents needed for registrations including notarization, apostillation or embassy certificationsYour Profile:
Minimum Bachelor in Engineering or Natural Science, Master is desirable but not mandatory1-3 years of professional experience in internationally operating companies, including at least 1 year in the medical device industry within regulatory affairs or quality managementStrong stakeholder management and communication skills, while continuously learning and adapting to changing environmentsStrong expertise in RA and global regulatory requirementsStrong project management skills, highly structured and systematic working styleExcellent knowledge of FME business and productsFluent in English, additional language skills (e.g., German) considered a plusWillingness 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 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
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