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

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

Bewerben
remote type
Hybrid
locations
Bad Homburg, Germany
DEU Schweinfurt-Plant-HB6-10
DEU Schweinfurt-Plant-H9
St. Wendel, Germany
time type
Vollzeit
posted on
Gestern ausgeschrieben
job requisition id
R0202138
Your Purpose:
As Senior Director of the Global Biocompatibility and Toxicology Competence Center, you will be responsible for establishing and leading a globally aligned, high-performing team of experts. Your mission is to define and implement FME’s overarching 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, both professionally and disciplinarily.
• Derive overarching biocompatibility strategy for all relevant products of Care Enablement, i.e., medical devices and primary packaging materials for drugs.
• Process-owner for biocompatibility SOP package within FME’s QMS.
• Strong involvement and integration in development and sustaining projects with the team’s expertise.
• Professional and transparent resource management and prioritization of tasks
• Derive an overarching strategy biocomp strategy (sampling, testing, evaluation etc.) with all verticals.
• Align sampling and testing strategies and support product responsibles/product development groups to apply them.
• Qualification of test laboratories and subsequent alignment of requirements for studies, e.g., AET, test methods, etc.
• Support evaluation of analytical and biological results gained by internal or external testing labs.
• Oversee the creation of biocomp files including BEP (biological evaluation plant), BER (biological evaluation report) TRA (toxicological risk evaluation) 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.
• Manage interfaces and stakeholder relations to R&D teams within CE Verticals, incl. communication of global biocompatibility and toxicology strategy and priorities.

Your profile

• 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.
• Knowlede in risk management is a plus
• Strong leadership experience in an international context and matrix environment, supporting and fostering performance culture and individual and team accountability
• Strategic and visionary personality able to balance between short-term priorities and long-term vision
• 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.
• Committed to continuous learning and able to thrive in a dynamic environment.
• Fluent in business English; additional languages (e.g., German, French, Italian) are a plus.

Our offer for you:
There is a lot you can discover at Fresenius Medical Care because we have a lot to offer. No matter what field you are an expert in and how much experience you have - for your professional future with meaning:

• The opportunity to work in a hybrid model
• Whether in front of or behind the scenes - you will help to make better medicine accessible to more and more people around the world
• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
• A large number of committed people with a wide range of skills, talents and experience
• The benefits of a successful global corporation with the collegial culture of a medium-sized company