Biocompatibility Program Manager
Core
Establishing and directing the biocompatibility program to ensure patient safety and regulatory compliance for medical device products.
Role type
Senior Program Manager (Biocompatibility)
Builds
Biocompatibility evaluation plans, test reports, and final compliance documentation for new and existing medical devices.
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biocompatibility testing methods (cytotoxicity, sensitization, irritation, extractables/leachables), ISO-10993 and ISO-14971 regulations, FDA and EU-MDR compliance, statistical analysis of test data, vendor management, budget management, SAP/Windchill/CAD proficiency
Preferred skills
Advanced education in toxicology or microbiology
Technologies
SAP, Windchill, CAD
Responsibilities
Author and approve biocompatibility evaluation plans and reports; manage external vendors and consultants; train staff on regulatory compliance; present program updates to executive leadership; support new product development across business units; manage biocompatibility budget and project initiatives.
Seniority
Senior, hands-on IC with team management potential
