Call center agent Jobs in Bexbach

Your Purpose :

As 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 FMEs 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 FMEs QMS.
• Strong involvement and integration in development and sustaining projects with the teams 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 :

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 :

Required Experience :

Director

Key Skills

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Employment Type : Full-Time

Experience : years

Vacancy : 1