Expert Regulatory Intelligence (m/w/d)
Epredia
Fresenius Medical Care is the world’s leading provider of products and services by offering innovative products and treatment concepts of the highest quality. We continuously want to improve the quality of life for our dialysis patients, worldwide and every day.
Join our team and play a pivotal role in shaping the future of dialysis care, driving impactful innovations and strategies that enhance patient outcomes on a global scale!
Your responsibilities:
Collect, monitor, and communicate global regulatory requirements, including standards, laws, and guidelines, for product lifecycle, quality, and environmental managementAct as a liaison between country hubs, experts, business units, and central functions to gather and evaluate regulatory requirementsInitiate and manage gap analyses for new or updated regulations as the central point of contactAdminister standard management systems like Beuth eNorm and Techstreet, including licensingFacilitate gap analyses and ensure follow-up actions are completedCommunicate regulatory updates and implement necessary measuresSupport the creation of quality management system (QMS) inputs, such as management review materialsHelp vertical teams compile lists of applicable standards, laws, and guidelinesYour profile:
Master’s degree in engineering, natural sciences, or a related field3+ years of experience in regulatory affairs, including monitoring regulatory requirementsExpertise in global regulatory requirements, including standards, laws, and guidelines across QMS and EHSStrong project management skills and a structured, systematic approachFamiliarity with FME’s business and products is a plusExcellent communication and stakeholder management skills, with the ability to explain complex topics clearlyWillingness to learn and adapt to new challengesFluent in business EnglishOur offer to you:
There is a lot for you to discover at Fresenius Medical Care, because we have a lot to offer. No matter in which field you are an expert and how much experience you bring with you - for your professional future with meaning:
The opportunity to work on a mobile basisWhether in front of or behind the scenes - you will help to make better and better therapy 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, not the fastest, solution togetherA 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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