Your responsibilities:

Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labelingEnsure compliance with regulatory standards and testing requirements throughout product design and developmentCoordinate regulatory approvals and change notifications with Notified Bodies and AuthoritiesEnsure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissionsCoordinate regulatory strategies for FME products and oversee preparation of Free Sale Certificates, declarations, and site registrationsLead regulatory aspects of product and process changes, including Declarations of Conformity, documentation, and marketing material reviews

Your profile:

Bachelor’s degree in Technical, Engineering, or Scientific fieldsMinimum of 1 year in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal ProductsKnowledge of development and manufacturing processes (at least 2 years)Familiarity with quality management and risk management standards (e.g., ISO 13485, ISO 14971)Understanding of medical device regulations (e.g., MDD 93/42/EEC, MDR 2017/745)Strong communication and interpersonal skillsFluent 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:

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

Kindly be advised that this position is limited to 18-months.