Staff Toxicologist

The Staff Toxicologist will perform toxicological risk assessments for chemical characterization, extractables/leachables (E&L) data, and other safety evaluations for medical devices and drug-device combination products. This includes literature reviews, computational modeling, and risk assessment strategies. Coordinate with internal laboratories to review and interpret test lab reports, ensuring high-quality data for regulatory submissions. Guide regulatory submissions for FDA (CDRH) and EU MDR compliance, focusing on meeting regional and global requirements. Act as the primary contact for regulatory agencies and serve as an expert in all matters related to medical device toxicology. Contribute to developing new protocols for toxicological assessments and mentor junior toxicologists.