Associate Director - Biocompatibility & Toxicology

Role: Lead global biocompatibility program for medical devices, focusing on biological safety testing strategy, toxicological risk assessments, and regulatory documentation. Responsibilities include authoring test plans, supporting product development, ensuring compliance with ISO 10993 standards, providing scientific analysis of safety data, and managing cross-functional teams. The position involves overseeing external CROs, maintaining SOPs, and leading biocompatibility training. Qualifications: 10+ years in toxicology or related fields, with a MS or PhD (DABT preferred), extensive experience in medical device biocompatibility, chemical characterization, and risk assessments. Expertise in GLP/nGLP studies, regulatory standards (US, EU, APAC), and budget management is required. High-value specifics include medical device safety evaluation, biological safety testing, and chemical characterization within the regulatory framework. The role may involve domestic and international travel and team leadership responsibilities.