Toxicologist Subject Matter Expert

Job Summary

To support FDA medical device evaluations, the full-time Toxicologist Subject Matter Expert will serve as a technical authority in scientific analysis, conducting risk assessments and providing authoritative analysis of safety and effectiveness data, while working remotely.

Key responsibilities

• Conduct assessments of risks to human health from exposure to chemicals and evaluate adverse responses associated with medical devices
• Provide authoritative analysis of scientific data submitted for medical device review by the FDA
• Collaborate with cross-functional teams to support toxicological evaluations and ensure compliance with relevant standards and guidances

Required qualifications

• PhD in Toxicology, Biology, or Chemistry from an accredited institution
• Minimum of five years of experience in toxicological risk assessment and chemical hazard identification
• Knowledge of FDA Biocompatibility Guidance and ISO standards related to medical devices
• Experience with in silico and computational methodologies for toxicological assessments is beneficial
• Board certification or relevant certifications in toxicology is highly preferred