Not specified (assumed office-based due to the nature of the role)
Biocompatibility program management
Iso-10993 and iso-14971 regulations
Cytotoxicity and sensitization testing
Acumed LLC is seeking a Biocompatibility Program Manager to lead the biocompatibility program, ensuring compliance with standards for the safety of medical products. The role involves cross-functional collaboration, managing biocompatibility initiatives, and engaging with stakeholders, including the executive team
Job Summary
The role involves establishing and directing all aspects of the biocompatibility program to ensure safe use of products in patients across Acumed's business units.
Candidates will work within a matrixed environment to influence stakeholders, manage external vendors, and present program updates to the executive team.
The position requires applying appropriate testing methods like cytotoxicity and irritation while maintaining compliance with FDA, EU-MDR, and ISO standards.
Matching Summary
Match Score: 85
Acumed LLC is seeking a Biocompatibility Program Manager to lead the biocompatibility program, ensuring compliance with standards for the safety of medical products. The role involves cross-functional collaboration, managing biocompatibility initiatives, and engaging with stakeholders, including the executive team.
Skills & Requirements
Must-have
Biocompatibility program management
ISO-10993 and ISO-14971 regulations
Cytotoxicity and sensitization testing
Cross-functional team leadership
External vendor management
Nice-to-have
Advanced education in toxicology
Strong statistical analysis skills
Experience with SAP and Windchill
Executive presentation capabilities
Matrixed organization experience
Key Requirements
Bachelor's degree in biological or physical sciences
Minimum 5 years of biocompatibility experience
Proficiency in surgical invasive and implantable principles