At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—"Creating a future worth living. For patients. Worldwide. Every day."—we work with purpose and compassion, supported by a global team of over 125,000 employees.Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.Our values guide how we work:We Care for our patients, each other, and our communitiesWe Connect across teams and borders to deliver excellence togetherWe Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovationSystems, Quality & Regulatory (SQR) is a global function within Care Enablement ensuring Fresenius Medical Care's products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post‐market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product‐related business services across global operations. Join our passionate team and help shape healthcare worldwide!Your Responsibilities asExpert Quality & Regulatory EMEA : Q&R Administrative Compliance & Documentation GovernanceDesign, implement, and maintain an efficient document management systemManage daily documentation activities and ensure consistency with internal policies and regulatory requirementsPrepare presentations, executive summaries, structured reports, and data overviews to support leadership decision‐makingGenerate consolidated periodic reports and maintain data transparency for management reviewManage in documenting and updating internal processes and changesCoordinate translations of departmental documents, ensuring consistency and accuracy across regions where requiredContribute to regional and cross‐functional operational improvement initiativesSupport the implementation, monitoring, and optimization of dedicated Q&R systems, IT and digital toolsOrganize meetings, track action items, and ensure timely follow‐up on decisions and deliverablesCoordinate business travel and support the organization of internal and external events in alignment with corporate policiesData & Project ManagementMaintain and support databases used for statistical data collection and reportingSupport in the implementation and follow‐up of Q&R projects and related IT toolsContribute to project execution by ensuring alignment with established processes, procedures, and Q&R compliance standardsPrepare project status reports outlining progress, challenges, risks, and proposed solutions using appropriate data management toolsSupport the development and application of standardized methods and tools to effectively organize and manage Q&R projectsCollaborate with functional and operational leaders across the organization to facilitate smooth transitions and successful project deliveryYour Profile:Bachelor's degree in Business Administration, Quality Management, Regulatory Affairs, Life Sciences, Health Sciences, or a related fieldCertification in documentation managementAt least 2 years of professional experience in documentation management, administration, quality management system, regulatory affairs, compliance administration, or comparableExperience in processing documentation and controlsExperience working within a regulated environment (e.g., healthcare, MedTech, pharma, or similar)Hands‐on experience with document management systems, reporting tools, and digital collaboration platformsKnowledge of documentation control principles and data integrity practicesGood understanding of Quality & Regulatory processes and compliance frameworksKnowledge of ISO 9001, ISO 13485 standards and ISO13485/MDR/GxP regulationsAbility to perform translations into EnglishProficient in MS Office applications (Excel, Word, PowerPoint) and collaboration tools (e.g., Sharepoint, Teams) at a good levelAbility to adapt to new technologiesKnowledge or competence to work with Power BI and AI toolsFluent in English (written and spoken)Based in Portugal, preferably based in PortoOur Offer For You:Individual 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 companyHealth insuranceLife insuranceMeal allowanceHybrid work#J-18808-Ljbffr