Expert Consultant - Biocompatibility Expert - US
Core
Senior scientific contributor leading biocompatibility assessments, biological evaluations, and risk assessments for medical device products in global, highly regulated environments.
Role type
Senior IC biocompatibility consultant (strategy & advisory)
Builds
Regulator-ready biocompatibility assessments and biological evaluations for medical device clients
Domain
Medical device industry + biocompatibility/toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biocompatibility assessment expertise, ISO 10993 application, FDA-regulated environment knowledge, technical writing, regulatory document authorship, peer review, literature-based evaluation, risk assessment, standards development participation
Preferred skills
Medical toxicology expertise, regulatory agency interaction experience, external-facing thought leadership
Technologies
ISO 10993, GMP, GLP
Responsibilities
Lead development and authorship of biocompatibility assessments and biological evaluations; Perform literature-based evaluations of materials and device use; Provide peer review and technical guidance on complex projects; Author opinion memos and regulatory-facing documentation; Serve as subject-matter expert during client discussions; Participate in international standards development and deliver technical presentations
Seniority
Senior, hands-on IC with strategic influence