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Risk Management Expert
7 ore fa
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 communities
- We Connect across teams and borders to deliver excellence together
- We Commit to doing things the right way— growing with purpose and leading kidney care with integrity and innovation
Information about department
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
Summary about role
As 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 Responsibilities
- Lead 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 transfer and ongoing manufacturing activities.
- Contribute to quality‑system risk assessments (complaints, non‑conformances, CAPAs) and Health Hazard Assessments.
- Support the creation of post‑market safety documentation (e.g., PSUR, CER) and act as a subject matter expert for risk management within cross‑functional teams.
Your Profile
- Scientific degree and minimum 2 years of experience in Regulatory Affairs or Quality within the pharma/medical device industry.
- Proven experience in risk evaluations and strong knowledge of medical device regulations and standards (e.g., MDR, MDSAP, ISO 13485, ISO
- Experience in scientific writing and familiarity with statistical methods.
- Knowledge of medical devices, including dialysis and related therapies.
- Strong analytical, organizational, and decision‑making skills, with an autonomous and structured working approach.
- Ability to work cross‑functionally at all organizational levels, with excellent communication skills in an international environment.
- High engagement, proactive problem‑solving attitude, and strong alignment with company values and objectives.
- Fluent English; advanced proficiency with MS Office, Outlook, SharePoint, Teams.
- Preferred: experience with TrackWise/QTRAK, PDM tools (e.g., Windchill), and FMEA tools.
- Willingness to travel 5–10%.
Our Offer for you
There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.
- Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world.
- Individual opportunities for self-determined career planning and professional development.
- A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one.
- A large number of committed people with a wide range of skills, talents and experience.
