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) Biocompatibility & Toxicological Expert (m/f/d) you will be responsible for biocompatibility evaluation of medical devices according to the ISO 10993-series and global regulatory guidelines/requirements.
Your Responsibilities
Lead biocompatibility and toxicology activities for a global medical device platform, including active devices and disposables
Define and drive the overall strategy for biological safety and toxicological evaluation across the product lifecycle
Take end-to-end accountability for key deliverables (e.g. biological evaluation plans/reports, toxicological risk assessments) in alignment with internal experts
Act as the central interface for cross-functional stakeholders, aligning requirements and prioritizing activities
Ensure compliant safety and risk assessments based on materials, extractables & leachables, and biocompatibility studies (ISO 10993)
Provide expert guidance and scientific assessments to support product development and regulatory submissions
Coordinate global biocompatibility activities and collaborate with internal competence centers, EHS, and Quality & Regulatory teams
Contribute to design control, regulatory compliance, and continuous improvement initiatives, including sustainability aspects
Successfully completed master’s degree in toxicology, chemistry, physics, life sciences, engineering, or a related field
Related working experience: 2–8 years, depending on level (Expert / Senior Expert)
Solid expertise in biocompatibility evaluation and toxicological risk assessment
Experience in project management or cross-functional coordination
Strong knowledge of medical device regulations and standards (e.g. MDR 2017/745, ISO 13485, ISO 14971, ISO 10993 series, FDA 21 CFR Part 820).
Good understanding of global quality management systems and regulatory environments
Strong analytical skills, structured working style, and experience in scientific writing; knowledge of statistical methods is a plus
Ability to work independently and lead cross-functional topics without direct disciplinary authority
Proactive, solution-oriented mindset with strong organizational and communication skills
Experience collaborating in international environments
Fluent in English and German/Italian written and spoken
Proficient in MS Office and familiar with relevant systems (e.g. TrackWise/QTRAK, Windchill, FMEA tools)
Experience in the medical device field; exposure to dialysis or related therapies is an advantage
Team-oriented mindset, global perspective, and ability to collaborate across corporate functions
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