Senior Director Global Biocompatibility and Toxicology Competence Center (m/w/d)

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Senior Director Global Biocompatibility and Toxicology Competence Center (m/w/d)

Apply: Remote type: Hybrid | Locations: Bad Homburg, Germany; Schweinfurt-Plant-HB6-10, Schweinfurt-Plant-H9, St. Wendel, Germany | Time type: Full time | Posted on: Posted Yesterday | Job requisition id: R0202138

Your Purpose:

As Senior Director of the Global Biocompatibility and Toxicology Competence Center, you will establish and lead a high-performing, globally aligned team of experts. Your mission is to define and execute FME’s biocompatibility strategy across medical devices and primary packaging materials, ensuring regulatory compliance and product safety in line with the highest standards of patient care.

Your Tasks:

• Build, lead, and develop the Global Biocompatibility and Toxicology Competence Center, overseeing professional and disciplinary aspects.
• Develop overarching biocompatibility strategies for all relevant products within Care Enablement, including medical devices and drug packaging materials.
• Manage the biocompatibility SOP package within FME’s QMS as the process owner.
• Engage actively in development and sustaining projects utilizing the team's expertise.
• Ensure professional and transparent resource management and prioritize tasks effectively.
• Formulate a comprehensive biocompatibility strategy (sampling, testing, evaluation, etc.) across all verticals.
• Align sampling and testing strategies, supporting product teams in their application.
• Qualify test laboratories and standardize requirements for studies (e.g., AET, test methods).
• Support the evaluation of analytical and biological results from internal or external labs.
• Oversee the creation of biocompatibility files, including BEP, BER, TRA, and risk assessments.
• Coordinate strategy alignment with regulatory agencies and notified bodies.
• Participate in standard committees and build networks with agencies and experts in biocompatibility.
• Manage interfaces and stakeholder relations with R&D teams within CE Verticals, communicating global strategies and priorities.

Your Profile:

• 7–10 years of hands-on experience in biocompatibility evaluation of medical devices and/or drug packaging materials.
• Expertise in biocompatibility testing methodologies; laboratory management experience is a strong asset.
• Deep knowledge of ISO 10993 series; relevant certifications and training preferred.
• Knowledge in risk management is a plus.
• Strong leadership experience in an international, matrix environment, supporting a performance-driven culture.
• Strategic, visionary personality capable of balancing short-term and long-term priorities.
• Excellent project management and organizational skills; detail-oriented.
• Strong communication and stakeholder management skills, capable of handling complex topics confidently.
• Experience with PTC Windchill PDM; knowledge of Polarion ALM is advantageous.
• Proficiency in Microsoft Office and related tools.
• Commitment to continuous learning and adaptability in dynamic environments.
• Fluent in business English; additional languages (German, French, Italian) are a plus.

Our Offer:

Discover numerous opportunities at Fresenius Medical Care, regardless of your expertise or experience level. We offer:

• The flexibility of a hybrid working model.
• The chance to help make better medicine accessible worldwide.
• Opportunities for self-directed career development.
• A culture encouraging innovative thinking and collaborative problem-solving.
• A diverse, talented workforce.
• The benefits of a global corporation combined with a collegial, medium-sized company culture.

About Us

Our Work Experience reflects our culture, values, commitment to sustainability, recognition programs, and, most importantly, our people—self-disciplined, hardworking, curious, trustworthy, humble, and truthful. Our employees prioritize teamwork, collaboration, and making a difference, earning us the title of #1 Top Workplace in the area.

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