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.
Our values guide how we work:
Systems, Quality & Regulatory (SQR), 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!
Lead global regulatory strategy and submissions across U.S., EU, Canada, LATAM, and APAC
Plan, author, and review eCTD submissions (IND, NDA, ANDA, MAA, variations, renewals, supplements)
Coordinate electronic submissions with Regulatory Operations using Veeva Vault RIM, RIMSmart, and global gateways (FDA ESG, CESP, BfArM, Health Canada, ANVISA)
