Regulatory Affaris ExpertAtFresenius Medical Care, we are the general 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 110,000 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 Carefor our patients, each other, and our communitiesWe Connectacross teams and borders to deliver excellence togetherWe Committo doing things the right way—growing with purpose and leading kidney care with integrity and innovationAt our Reynosa plant in Mexico, we are committed to the highest standards in the production of disposable medical products for dialysis treatments.With a dedicated team of more than 3,000 employees across four manufacturing sites, the plant focuses on manufacturing essential components such as hemodialysis disposables, peritoneal dialysis (PD) disposables, hemodialysis (HD) machines,



and PD cycler machines.By utilizing advanced technologies to ensure the highest standards in dialysis product manufacturing, we're not only driving innovation—we're also creating meaningful change for patients worldwide.Join our passionate team and be part of this global impact.The Regulatory Affairs Expert supports regulatory product availability on global markets in alignment with commercial strategy.This role is responsible for managing regulatory documentation, supporting global product registrations, ensuring regulatory compliance, and leading regulatory aspects of product and process changes throughout the product lifecycle.Your ResponsibilitiesPrepare, maintain, and manage Global Technical Documentation and Registration FilesDevelop and approve Instructions for Use (IFU), labeling, Service Manuals, and Installation GuidesProvide regulatory guidance on applicable standards, regulations, and testing requirementsSupport design and development projects from a regulatory perspectiveCoordinate global submissions, registrations, renewals, and change notifications with Regulatory Authorities and Notified BodiesConduct conformity assessments and support product risk classification activitiesCompile technical documentation, expert opinions, and risk evaluations supporting regulatory complianceParticipate in change control processes and evaluate product and process changes from a regulatory perspective#J-*****-Ljbffr

📌 Regulatory Affairs Expert (Reynosa)
🏢 Fresenius Medical Care
📍 Reynosa