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

Fresenius Medical Care

5d • Hybrid

About The Position

Fresenius Medical Care is hiring a Director to establish and lead its Global Biocompatibility and Toxicology Competence Center within the Systems, Quality & Regulatory (SQR) function of the Care Enablement segment. The role is responsible for defining and implementing a globally aligned biocompatibility strategy across medical devices and primary packaging materials for drugs, ensuring regulatory compliance and product safety.

The Director will build and develop a high-performing team, serve as process owner for the biocompatibility SOP package within the company’s quality management system, and integrate biocompatibility expertise into product development and sustaining projects. The role also oversees strategy for sampling, testing, evaluation, laboratory qualification, biological evaluation documentation, toxicological risk evaluation, and risk assessments. It collaborates with product development groups, regulatory agencies, notified bodies, standards committees, laboratories, and stakeholders across Care Enablement verticals.

The position calls for substantial hands-on biocompatibility experience, strong leadership in international and matrix environments, strategic and project-management capabilities, and effective communication with diverse stakeholders. The opportunity is offered in a hybrid work model, with professional development and career-planning opportunities.

Requirements

• 7–10 years of hands-on experience evaluating the biocompatibility of medical devices and/or drug packaging materials.
• Sound expertise in biocompatibility testing methodologies.
• Strong leadership experience in an international context and matrix environment, supporting performance culture and individual and team accountability.
• Strategic and visionary approach, with the ability 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, including the ability to explain complex topics clearly and confidently.
• Advanced experience with PTC Windchill PDM.
• Proficiency in Microsoft Office and related business tools.
• Commitment to continuous learning and ability to thrive in a dynamic environment.
• Fluent business English.

Nice To Haves

• Laboratory management experience.
• Relevant certifications and training in the ISO 10993 series.
• Knowledge of toxicology and risk management.
• Working knowledge of Polarion ALM.
• Additional languages such as German, French, or Italian.

Responsibilities

• Build, lead, and professionally and disciplinarily develop the Global Biocompatibility and Toxicology Competence Center.
• Derive the overarching biocompatibility strategy for relevant Care Enablement products, including medical devices and primary packaging materials for drugs.
• Own the biocompatibility SOP package process within Fresenius Medical Care’s quality management system.
• Integrate the team’s expertise into development and sustaining projects.
• Manage resources transparently and prioritize tasks.
• Develop biocompatibility strategies for sampling, testing, and evaluation in coordination with relevant verticals.
• Align sampling and testing strategies and support product owners and product development groups in applying them.
• 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 the creation of biocompatibility files, including biological evaluation plans, biological evaluation reports, toxicological risk evaluations, and risk assessments.
• Agree on strategies with regulatory agencies and notified bodies.
• Participate in standards committees and build networks with agencies and experts in biocompatibility.
• Manage interfaces and stakeholder relationships with R&D teams across Care Enablement verticals, communicating global biocompatibility and toxicology strategy and priorities.

Benefits

• Opportunity to work in a hybrid model.
• Individual opportunities for self-determined career planning and professional development.
• A corporate culture that makes room for innovative thinking and collaborative problem-solving.
• The benefits of a successful global corporation combined with the collegial culture of a medium-sized company.
• Commitment to diversity and equal opportunities; applications from people with disabilities are welcomed.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed