We are looking for a Regulatory Affairs Expert - Critical Care/Peritoneal Dialysis (m/f/d) in Bad Homburg or St. Wendel.

Your responsibilities:

Manage creation, maintenance, and approval of global regulatory documentation (e.g., technical files, registration dossiers, labeling, IFUs)Support global product registrations, renewals, and submissions, including compilation of STED files, declarations, and Free Sale CertificatesEnsure compliance with applicable standards, perform conformity assessments, and align product risk classificationsProvide regulatory input for design changes, development projects, and change control processesCoordinate global regulatory strategy, activities, and communications across marketsLead regulatory impact assessments, change implementation, and stakeholder alignmentSupport creation and review of Declarations of Conformity, marketing materials, and product-related documentationCollaborate on clinical evaluation content and provide expert opinions and risk evaluationsAssist with registration of manufacturing sites, kits, and trading goods; support tenders and pharma-related device submissions

Your profile:

Technical/Engineering/Scientific background (PhD, MBA, or relevant specialized education)Minimum 1 year professional experience in Regulatory or Quality Assurance for Medical Devices/Medicinal Products2+ years knowledge in development, manufacture, and control of Medical Devices/Medicinal ProductsFamiliarity with quality management and risk management standards (e.g., ISO 13485, ISO 14971, EU GMP Guidelines, FDA 21 CFR §820.250)Understanding of medical device regulations (MDD 93/42/EEC, MDR 2017/745)Knowledge of internal/external processes and corporate Quality Management requirementsExpertise in sterilization processes, clean room requirements, and validation methodsRegulatory knowledge on global registrationFluent in English and German

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 hybrid 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