Director, Global Biocompatibility and Toxicology Competence Center
Fresenius Medical Care
full-time
Posted on:
Location Type: Hybrid
Location: Bad Homburg • 🇩🇪 Germany
Visit company websiteJob Level
Lead
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
biocompatibility evaluationbiocompatibility testing methodologieslaboratory managementtoxicologyrisk managementISO 10993 seriesproject managementorganizational skillsstakeholder management
Soft skills
leadershipcommunicationstructureddetail-orientedclarityconfidence