Fresenius Medical Care
(Senior) Expert Audits(m/w/x)
Full-timeTemporary contractWith HomeofficeExperienced
Bad Homburg vor der Höhe
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FRFresenius Medical Care D. GmbH
(Senior) Biocompatibility & Toxicological Expert(m/w/x)
Bad Homburg vor der Höhe
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Global leadership in biocompatibility and toxicology for kidney care devices. Master’s degree and ISO 10993 expertise required. Career planning, professional development.
Requirements
- Master’s degree in toxicology, chemistry, physics, life sciences, engineering, or related field
- 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 (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 scientific writing experience
- 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
- 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
Tasks
- Conduct biocompatibility evaluations of medical devices
- Lead biocompatibility and toxicology activities globally
- Define and implement biological safety and toxicological strategies
- Ensure compliance with ISO 10993 and global regulatory guidelines
- Develop and maintain biological evaluation plans and reports
- Perform toxicological risk assessments
- Align with internal experts on key deliverables
- Act as central interface for cross-functional stakeholders
- Prioritize and coordinate biocompatibility activities
- Ensure compliant safety and risk assessments
- Provide expert guidance on product development and regulatory submissions
- Collaborate with EHS, Quality & Regulatory teams
- Contribute to design control and regulatory compliance
- Support continuous improvement and sustainability initiatives
Work Experience
- 2 - 8 years
Education
- Master's degree
Languages
- English – Fluent
- German – Fluent
- Italian – Fluent
Tools & Technologies
- MS Office
- TrackWise/QTRAK
- Windchill
- FMEA tools
Benefits
Career Advancement
- Career planning opportunities
Learning & Development
- Professional development
Informal Culture
- Innovative corporate culture
- Collegial company culture
Corporate Discounts
- Global corporation benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Medical Care D. GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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FRFresenius Medical Care D. GmbH
(Senior) Biocompatibility & Toxicological Expert(m/w/x)
Bad Homburg vor der Höhe
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Global leadership in biocompatibility and toxicology for kidney care devices. Master’s degree and ISO 10993 expertise required. Career planning, professional development.
Requirements
- Master’s degree in toxicology, chemistry, physics, life sciences, engineering, or related field
- 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 (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 scientific writing experience
- 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
- 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
Tasks
- Conduct biocompatibility evaluations of medical devices
- Lead biocompatibility and toxicology activities globally
- Define and implement biological safety and toxicological strategies
- Ensure compliance with ISO 10993 and global regulatory guidelines
- Develop and maintain biological evaluation plans and reports
- Perform toxicological risk assessments
- Align with internal experts on key deliverables
- Act as central interface for cross-functional stakeholders
- Prioritize and coordinate biocompatibility activities
- Ensure compliant safety and risk assessments
- Provide expert guidance on product development and regulatory submissions
- Collaborate with EHS, Quality & Regulatory teams
- Contribute to design control and regulatory compliance
- Support continuous improvement and sustainability initiatives
Work Experience
- 2 - 8 years
Education
- Master's degree
Languages
- English – Fluent
- German – Fluent
- Italian – Fluent
Tools & Technologies
- MS Office
- TrackWise/QTRAK
- Windchill
- FMEA tools
Benefits
Career Advancement
- Career planning opportunities
Learning & Development
- Professional development
Informal Culture
- Innovative corporate culture
- Collegial company culture
Corporate Discounts
- Global corporation benefits
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Fresenius Medical Care D. GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Fresenius Medical Care D. GmbH
Industry
Healthcare
Description
The company is dedicated to improving the lives of patients with chronic kidney disease through innovative, high-quality products and treatments.
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