Job Description

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

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!


In your role as (Senior) Toxicological Expert (m/f/d), you will be responsible for toxicological evaluations and risk assessments of medical devices in compliance with MDR (EU 2017/745), ISO 10993-17, and related regulatory guidelines.

Your tasks

==============

Derive strategy for toxicological evaluations and risk assessment acc. ISO 10993-17 for different product groups and therapies Support biocompatibility strategy details including material characterization, sampling of different product groups, chemical-analytical and biological testing as well as overall evaluation Analyze results of chemical-analytical and biological testing for their toxicological profiles Create toxicological risk assessments for leachables and extractables studies for all relevant products Perform toxicological evaluations of substances or if needed assignment of mandates for external toxicologists and review of respective assessments Support and coordinate with projects and product responsibles how to interpret the findings and measures to be taken, e.g., change of materials or production processes, measures to minimize leachables, etc. Revise existing toxicological risk evaluations or reports for substances to comply with state-of-the-art data Drive the global exchange and knowledge increase wrt toxicological evaluation of relevant substance groups and respective measures Support with toxicological expert know-how and contribute to the overall biocompatibility reports for the products

Your profile

================

Successfully completed master’s degree in scientific or engineering or a similar technical field required, such as medical technology Related working experience: 2–8 years, depending on level (Expert / Senior Expert) Advanced training in toxicology, e.g., avocational studies, trainings, etc. Certification as toxicologist or started education highly welcome, e.g., European Registered Toxicologist (ERT) or Board Certified Toxicologist (DABT). Deep knowledge of ISO 10993 standard series including respective trainings Significant experience in chemical-analytical as well as biological biocompatibility testing as well as evaluations

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 * The benefits of a successful global corporation with the collegial culture of a medium-sized company