Senior Biocompatibility Scientist
Core
Ensure patient safety by supporting biocompatibility projects for medical devices, materials, and processes, acting as a Subject Matter Expert in compliance with global regulations like ISO 10993.
Role type
Senior Biocompatibility Scientist (IC)
Builds
Biological evaluation safety plans, regulatory documents, testing protocols, and laboratory reports for Class II to Class III medical devices.
Domain
Medical Devices / Biocompatibility / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biocompatibility assessment methodology, ISO 10993 standards, toxicological risk assessment, extractable and leachable analysis, medical device manufacturing processes, technical writing for FDA/Notified Bodies, gap analysis, risk-based framework application.
Preferred skills
Master's degree in relevant field, experience in pharmaceutical or biotechnology fields.
Technologies
MS Office (Word, Excel, Outlook, PowerPoint, SharePoint, OneDrive, CoPilot)
Responsibilities
Prepare and finalize biological evaluation safety plans and regulatory documents; analyze biocompatibility test results to determine data adequacy and troubleshoot unexpected results; review and approve biocompatibility assessments within a risk-based framework; participate in design and risk review meetings to address biological safety concerns; assist with regulatory submissions to global agencies; collaborate with cross-functional teams to support multiple projects.
Seniority
Senior, hands-on IC
