Lavori attuali relativi a Risk Management Expert - Palazzo Pignano - Fresenius Medical Care
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Risk Management Expert
9 ore fa
Risk Management ExpertAt 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 innovationInformation about departmentSystems, 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 worldwideSummary about roleAs a Risk Management Expert, your role will be focus on ensuring the safety of medical devices by applying the risk management process throughout the product life cycle. You will identify and address risks in line with the Risk Management Plan and oversee the planning and execution of all risk management activities. You will prepare and maintain risk analyses for assigned medical devices, medicinal products, and—when applicable—digital or non‑medical devices, in compliance with relevant standards and guidelines.Your ResponsibilitiesLead the planning and execution of the risk management process in compliance with applicable standards and regulations.Develop, update, and maintain risk analyses and the Risk Management File across the product lifecycle.Define effective risk‑reduction measures in collaboration with cross‑functional partners and the Value Stream.Ensure all risk management activities align with the approved Risk Management Plan.Participate in product development and design reviews to verify proper risk identification and mitigation.Support and review Design/Process/Software FMEAs and anomaly management activities.Conduct and integrate risk assessments into the overall risk analysis.Provide risk management support during production
