Principal I, Microbiology & Toxicology

Role: Medical Device Toxicologist responsible for biological safety evaluation and biocompatibility strategies across the product lifecycle. Responsibilities: develop risk-based evaluation plans, author and review Biological Evaluation documentation, apply ISO 10993 standards, integrate chemical/material data for risk assessments, and support regulatory submissions. Serve as subject matter expert, evaluate complex data, identify safety risks, lead biocompatibility workstreams, and contribute to global regulatory responses. Requirements: Bachelor's degree or equivalent with 5+ years relevant experience; fluency in English. Preferred: MS or PhD in Toxicology or related fields, industry experience in medical devices/pharmaceuticals, knowledge of global regulations (EU MDR, FDA, REACH, Proposition 65), and experience with toxicology tools, external oversight, and regulatory submissions. High-value: focus on medical device biocompatibility, ISO 10993 standards, chemical/material risk assessment, and regulatory interactions. Work setup: On-site in Fort Worth, Texas.