Senior Biocompatibility Scientist

Conduct retrospective biocompatibility gap assessments across legacy product families, generating or compiling documentation to establish a comprehensive baseline of biological safety evidence Support sustaining and change management activities by providing strategic assessment of biological safety impact in accordance with ISO 10993-1 Develop and execute biocompatibility evaluation plans (BEPs) for new product development initiatives in accordance with ISO 10993-1 and FDA guidance, aligned to device classification, contact type, and contact duration Author and review biological evaluation reports (BERs), toxicological risk assessments (TRAs), and material characterization reports supporting 510(k), PMA, De Novo, and international submissions (CE marking under MDR, etc.) Manage biocompatibility testing programs with contract testing laboratories, ensuring GLP compliance and scientifically sound study design Apply risk-based approaches to minimize redundant testing, leveraging existing data where scientifically justified Support post-market and complaint driven biological safety assessments Serve as biocompatibility subject matter expert during FDA/notified body interactions, audits, and responses to regulatory questions or deficiency letters Develop and maintain SOPs, templates, and standardized workflows for biocompatibility evaluations to improve consistency, efficiency, and audit-readiness across the organization #J-18808-Ljbffr Physiol