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Acumed LLC is seeking a Biocompatibility Program Manager responsible for overseeing the biocompatibility program to ensure compliance with safety standards for medical devices. The ideal candidate will have extensive experience in biocompatibility principles, project management, and cross-functional collaboration.
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Job Summary
The Biocompatibility Program Manager is responsible for establishing and directing all aspects of the biocompatibility program to ensure safe use of products in patients.
This role requires working cross-functionally within a matrixed environment to apply biocomp principles to new product development across all business units.
Candidates must manage external vendors, control budgets, and present program updates to executive leadership while maintaining compliance with global standards.
Matching Summary
Match Score: 75
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Acumed LLC is seeking a Biocompatibility Program Manager responsible for overseeing the biocompatibility program to ensure compliance with safety standards for medical devices. The ideal candidate will have extensive experience in biocompatibility principles, project management, and cross-functional collaboration.
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Skills & Requirements
Must-have
Biocompatibility program management
ISO-10993 and ISO-14971 regulations
FDA and EU-MDR compliance
Cytotoxicity and sensitization testing
Project management tools proficiency
Statistical analysis of test data
Vendor and consultant management
Nice-to-have
Advanced education in toxicology
Experience with SAP and Windchill
Strong technical writing skills
Matrixed organization experience
Executive team presentation skills
Key Requirements
Bachelor's degree in biological or physical sciences
Minimum 5 years of biocompatibility experience
Proficiency in surgical invasive and implantable principles