Hybrid Director, Global Biocompatibility and Toxicology Competence Center

at Fresenius Medical Care

• Job title: Director, Global Biocompatibility and Toxicology Competence Center
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Bad Homburg, Germany

About the role

• Director leading Global Biocompatibility and Toxicology Competence Center at Fresenius Medical Care. Responsible for strategy implementation and team leadership in biocompatibility across medical devices.

Responsibilities

• Establishing and leading a globally aligned, high-performing team of experts
• Defining and implementing FME’s overarching biocompatibility strategy across medical devices and primary packaging materials
• Build, lead, and develop the Global Biocompatibility and Toxicology Competence Center
• Derive overarching biocompatibility strategy for all relevant products of Care Enablement
• Process-owner for biocompatibility SOP package within FME’s QMS
• Align sampling and testing strategies and support product responsibles/product development groups to apply them
• Oversee the creation of biocomp files including BEP, BER, TRA and risk assessments
• Agree strategy with regulatory agencies and notified bodies
• Actively work in standard committees and create network to agencies and experts in the field of biocompatibility

Requirements

• 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
• 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
• Fluent in business English; additional languages (e.g., German, French, Italian) are a plus

Benefits

• The opportunity to work in a hybrid model
• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking
• The benefits of a successful global corporation with the collegial culture of a medium-sized company