Regulatory Affairs Expert (Medical Devices)
Your responsibilities:
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Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling
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Ensure compliance with regulatory standards and testing requirements throughout product design and development
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Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities
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Ensure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissions
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Coordinate regulatory product strategies
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Lead regulatory aspects of product and process changes, including regulatory documentation.
Your profile:
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Master’s degree in Technical, Engineering, or Scientific fields
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Minimum of 8-10 years in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal Products
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Knowledge of development and manufacturing processes
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Familiarity with quality management and risk management standards (e.g., ISO 13485, ISO 14971, IEC 60601 series)
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Understanding of medical device regulations (e.g., FDA CFR, NMPA, MDR 2017/745)
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Strong communication and interpersonal skills
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Fluent in English, both written and spoken
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:
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The option to work on a hybrid basis
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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
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Individual opportunities for self-determined career planning and professional development
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A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
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A large number of committed people with a wide range of skills, talents and experience
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The benefits of a successful global corporation with the collegial culture of a medium-sized company
