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Biocompatibility & Toxicological Expert

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Fresenius Kidney Care Eupora

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Location:
Germany , Bad Homburg

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

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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) 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.

Job Responsibility:

  • 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

Requirements:

  • 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

Nice to have:

  • knowledge of statistical methods is a plus
  • exposure to dialysis or related therapies is an advantage
What we offer:
  • 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

Additional Information:

Job Posted:
May 16, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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