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

Your Purpose:

As Senior Director of the Global Biocompatibility and Toxicology Competence Center, you will be responsible for establishing and leading a high-performing, globally aligned team of experts. Your mission is to define and implement 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:

1. Build, lead, and develop the Global Biocompatibility and Toxicology Competence Center, both professionally and disciplinarily.
2. Develop overarching biocompatibility strategies for all relevant products of Care Enablement, including medical devices and primary packaging materials for drugs.
3. Serve as process owner for the biocompatibility SOP package within FME’s QMS.
4. Engage actively in development and sustaining projects with the team’s expertise.
5. Manage resources professionally and prioritize tasks effectively.
6. Formulate overarching biocompatibility strategies (sampling, testing, evaluation, etc.) across all verticals.
7. Align sampling and testing strategies and support product teams in their application.
8. Qualify test laboratories and standardize requirements for studies (e.g., AET, test methods).
9. Support the evaluation of analytical and biological results from internal or external labs.
10. Oversee creation of biocompatibility files, including BEP, BER, TRA, and risk assessments.
11. Align strategies with regulatory agencies and notified bodies.
12. Participate in standard committees and build networks with agencies and biocompatibility experts.
13. Manage interfaces and stakeholder relations within R&D teams, communicating global biocompatibility and toxicology strategies and priorities.

Your Profile:

1. 7–10 years of practical experience in the biocompatibility evaluation of medical devices and/or drug packaging materials.
2. Expertise in biocompatibility testing methodologies; laboratory management experience is a strong asset.
3. Deep knowledge of ISO 10993 series; relevant certifications and training preferred.
4. Knowledge in risk management is advantageous.
5. Strong leadership experience in an international, matrix environment, supporting performance culture and accountability.
6. Strategic, visionary mindset capable of balancing short-term priorities with long-term goals.
7. Excellent project management and organizational skills; structured and detail-oriented.
8. Strong communication and stakeholder management skills, capable of handling complex topics confidently.
9. Advanced experience with PTC Windchill PDM; familiarity with Polarion ALM is a plus.
10. Proficient in Microsoft Office and related tools.
11. Committed to continuous learning and adaptability in a dynamic environment.
12. 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, for a meaningful professional future:

• The chance to work in a hybrid model.
• Contribute to making better medicine accessible worldwide, whether in front of or behind the scenes.
• Opportunities for self-directed career planning and professional development.
• A corporate culture that encourages innovative thinking to find the best solutions, not just the quickest.
• Collaboration with a diverse team of skilled, talented, and experienced professionals.
• The benefits of a successful global company combined with a medium-sized company’s collegial culture.

#J-18808-Ljbffr