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Director Global Biocompatibility and Toxicology Competence Center
Fresenius Medical Care. Build, lead, and develop the Global Biocompatibility and Toxicology Competence Center, both professionally and disciplinary .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in biocompatibility evaluation and testing methodologies for medical devices and drug packaging, alongside strong leadership and project management skills in an international context. Proficient in managing stakeholder relations and aligning biocompatibility strategies with regulatory requirements.
Highest-signal resume keywords
Biocompatibility EvaluationISO 10993 KnowledgeLaboratory ManagementProject ManagementStakeholder Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Biocompatibility Testing MethodologiesToxicology KnowledgeRisk ManagementAnalytical EvaluationBiocompatibility SOP DevelopmentSampling and Testing StrategiesBiocompatibility File CreationRegulatory Strategy AlignmentTest Laboratory QualificationContinuous Learning
Soft Skills
Leadership ExperienceStrategic VisionOrganizational SkillsCommunication SkillsDetail Oriented
Tools & Technologies
PTC Windchill PDMPolarion ALMMicrosoft Office
Certifications & Qualifications
Relevant Certifications and Training
Industry Keywords
BiocompatibilityToxicologyMedical DevicesDrug PackagingQuality Management System (QMS)
About the role
Key responsibilities & impact- Build, lead, and develop the Global Biocompatibility and Toxicology Competence Center, both professionally and disciplinary
- Derive and implement the overarching biocompatibility strategy for medical devices and primary packaging materials for drugs
- Own the biocompatibility SOP package within FME’s QMS
- Support development and sustaining projects with biocompatibility and toxicology expertise
- Manage and prioritize resources and tasks transparently
- Align sampling and testing strategies across organizational verticals
- Support product-responsible and product-development groups in applying sampling and testing strategies
- Qualify test laboratories and align requirements for studies, including AET and test methods
- Support evaluation of analytical and biological results from internal and external testing laboratories
- Oversee creation of biocompatibility files, including BEP, BER, TRA, and risk assessments
- Agree strategy with regulatory agencies and notified bodies
- Work in standards committees and build networks with agencies and field experts
- Manage interfaces and stakeholder relations with R&D teams within Care Enablement Verticals
- Communicate global biocompatibility and toxicology strategy and priorities
Requirements
What you’ll need- 7–10 years of hands-on experience in the biocompatibility evaluation of medical devices and/or drug packaging materials
- Sound expertise in biocompatibility testing methodologies
- Laboratory management experience is a strong asset
- In-depth knowledge of the ISO 10993 series
- Relevant certifications and training preferred
- Knowledge in toxicology and risk management is a plus
- Strong leadership experience in an international context and matrix environment
- Strategic and visionary personality able to balance short-term priorities and long-term vision
- Excellent project management and organizational skills; structured and detail oriented
- Strong communication and stakeholder management skills; capable of handling complex topics with clarity and confidence
- Advanced experience with PTC Windchill PDM
- Working knowledge of Polarion ALM is a plus
- Proficient in Microsoft Office and related business tools
- Committed to continuous learning and able to thrive in a dynamic environment
- Fluent in business English
- Additional languages (e.g., German, French, Italian) are a plus
Benefits
Comp & perks- The opportunity to work in a hybrid model
- Individual opportunities for self-determined career planning and professional development
- Corporate culture with room for innovative thinking
- Benefits of a successful global corporation with the collegial culture of a medium-sized company
- Diversity and equal opportunities
- Applications welcomed from people with disabilities