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Baxter Healthcare is seeking an Associate Scientist I to perform biological risk assessments and manage biocompatibility testing for medical devices, ensuring compliance with safety standards. The ideal candidate should possess knowledge of ISO 10993 standards and have experience with regulatory documentation, contributing to a culture focused on healthcare innovation and accountability.
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Job Summary
The role involves performing biological risk assessments to determine biocompatibility testing required for product safety.
Candidates will manage biocompatibility testing at external laboratories within budget and according to project landmarks.
The position requires developing knowledge of ISO 10993 series standards for executing biological assays and toxicological risk assessments.
Matching Summary
Match Score: 75
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Baxter Healthcare is seeking an Associate Scientist I to perform biological risk assessments and manage biocompatibility testing for medical devices, ensuring compliance with safety standards. The ideal candidate should possess knowledge of ISO 10993 standards and have experience with regulatory documentation, contributing to a culture focused on healthcare innovation and accountability.
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Skills & Requirements
Must-have
Biological risk assessments
ISO 10993 standards knowledge
Team Center Unified (TCU) experience
Trackwise 8 system usage
Electronic Laboratory Notebook (ELN)
GLP/GMP regulatory compliance
Nice-to-have
Global compendia knowledge USP EP JP
External laboratory study monitoring
Regulatory filing document preparation
BEP/BER authoring skills
Collaborative team culture fit
Key Requirements
Working knowledge of Good Laboratory Practice (GLP)
Understanding of Good Manufacturing Practice (GMP)