Fresenius Medical Care
(Senior) Expert Audits(m/w/x)
VollzeitBefristeter Vertragmit HomeofficeBerufserfahren
Bad Homburg vor der Höhe
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
FRFresenius Medical Care D. GmbH
(Senior) Biocompatibility & Toxicological Expert(m/w/x)
Bad Homburg vor der Höhe
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Global leadership in biocompatibility and toxicology for kidney care devices. Master’s degree and ISO 10993 expertise required. Career planning, professional development.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 2 - 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – fließend
- Italienisch – fließend
Tools & Technologien
- MS Office
- TrackWise/QTRAK
- Windchill
- FMEA tools
Benefits
Karriere- und Weiterentwicklung
- Career planning opportunities
Weiterbildungsangebote
- Professional development
Lockere Unternehmenskultur
- Innovative corporate culture
- Collegial company culture
Mitarbeiterrabatte
- Global corporation benefits
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Fresenius Medical Care D. GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Noch nicht perfekt?
- Fresenius Medical Care
(Senior) Expert Integrated Diagnostics(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenBad Homburg vor der Höhe - Fresenius Medical Care D. GmbH
Senior Expert Audits(m/w/x)
VollzeitBefristeter Vertragmit HomeofficeSeniorBad Homburg vor der Höhe - Fresenius Medical Care D. GmbH
Head of Design Quality Assurance(m/w/x)
Vollzeitmit HomeofficeSeniorBad Homburg vor der Höhe - Fresenius Medical Care D. GmbH
Expert Medical Systems Products(m/w/x)
VollzeitBefristeter Vertragmit HomeofficeBerufserfahrenBad Homburg vor der Höhe
FRFresenius Medical Care D. GmbH
(Senior) Biocompatibility & Toxicological Expert(m/w/x)
Bad Homburg vor der Höhe
Vollzeitmit HomeofficeBerufserfahren
Nejo KI-Zusammenfassung
Global leadership in biocompatibility and toxicology for kidney care devices. Master’s degree and ISO 10993 expertise required. Career planning, professional development.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 2 - 8 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – fließend
- Italienisch – fließend
Tools & Technologien
- MS Office
- TrackWise/QTRAK
- Windchill
- FMEA tools
Benefits
Karriere- und Weiterentwicklung
- Career planning opportunities
Weiterbildungsangebote
- Professional development
Lockere Unternehmenskultur
- Innovative corporate culture
- Collegial company culture
Mitarbeiterrabatte
- Global corporation benefits
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Fresenius Medical Care D. GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Fresenius Medical Care D. GmbH
Branche
Healthcare
Beschreibung
The company is dedicated to improving the lives of patients with chronic kidney disease through innovative, high-quality products and treatments.
Noch nicht perfekt?
- Fresenius Medical Care
(Senior) Expert Audits(m/w/x)
VollzeitBefristeter Vertragmit HomeofficeBerufserfahrenBad Homburg vor der Höhe - Fresenius Medical Care
(Senior) Expert Integrated Diagnostics(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenBad Homburg vor der Höhe - Fresenius Medical Care D. GmbH
Senior Expert Audits(m/w/x)
VollzeitBefristeter Vertragmit HomeofficeSeniorBad Homburg vor der Höhe - Fresenius Medical Care D. GmbH
Head of Design Quality Assurance(m/w/x)
Vollzeitmit HomeofficeSeniorBad Homburg vor der Höhe - Fresenius Medical Care D. GmbH
Expert Medical Systems Products(m/w/x)
VollzeitBefristeter Vertragmit HomeofficeBerufserfahrenBad Homburg vor der Höhe