Staff Biocompatibility Scientist
Core
Lead biological evaluations, risk assessments, and testing strategies for complex medical devices across new product development and sustaining projects.
Role type
Staff Biocompatibility Scientist
Builds
Biological safety documentation, risk assessments, and regulatory technical responses for medical devices
Domain
Medical Devices / Biocompatibility / Regulatory Affairs
Required skills
ISO 10993-1:2025 application, biological risk assessment, microbiology testing, sterilization validation, toxicological risk assessment, design controls, regulatory gap analysis
Preferred skills
FDA submission support, EU MDR documentation, regulatory inspection participation, supplier audit experience
Technologies
ISO 10993-1:2025, ISO 14971
Responsibilities
Develop and maintain biological evaluation strategies and risk assessments; Evaluate material and process information for biological safety; Plan and execute microbiology activities including sterility and endotoxin testing; Develop cleaning and sterilization validation strategies; Coordinate external laboratory studies; Monitor regulatory standards and prepare technical responses to authorities
Seniority
Staff, hands-on IC with leadership