Toxicologist - Subject Matter Expert for FDA

Toxicologist Subject Matter Expert for FDA 

Educational Requirements:  Applicants should possess a PhD in Toxicology, or Biology and Chemistry with the ability to demonstrate mastery of principles, practices, and theories in the field of toxicology and risk assessment. This candidate must serve as a technical authority in the scientific analysis of the safety and effectiveness of medical devices, and provide an authoritative analysis of scientific data submitted to the Agency to support scientific evaluations required for medical device review by FDA.

Qualifications: 

• A PhD, or equivalent advanced degree, from an accredited or pre-accredited university in Toxicology, or Biology and Chemistry.
• A minimum of five years of experience conducting assessments of risks to human health from exposure to chemicals, chemical hazard identification, and selection of studies for quantitative dose-response and exposure assessments, including assessment of adverse responses and relevant mechanism(s) of material/tissue interactions associated with extractables and leachables from polymers and metal alloys using approaches within the disciplines of toxicology, immunotoxicology, and genetic toxicology.
• Experience related to medical devices is highly desirable.
• Knowledge of the scientific principles, theories and practices associated with the discipline of toxicology and the assessment of risks to human health posed by chemicals, extractables, and leachables.
• Experience with in silico and computational methodologies for toxicological risk assessment would be beneficial, and evidence of a strong track record of research and peer-reviewed publications in chemical hazard identification, toxicology, and risk assessment could also be beneficial.
• Familiar with the applicable guidances and standards, including, but not limited to the following:
• FDA Biocompatibility Guidance
• Basics of Biocompatibility: Information Needed for Assessment by the FDA
• Standards:
  • ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
  • ISO 10993-17:2002, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
  • ISO 10993-18:2020, Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
  • ISO TS 21726:2019, Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
  • ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (2017; R2018)

Additional Information:

• Board certification or related, relevant certifications required, e.g., DABT, American Board of Toxicology, Academy of Toxicological Sciences, etc.
• The successful candidate must be able to function independently and as part of matrixed teams involving federal and other contract staff of various disciplines and backgrounds.
• Must be able to successfully work remotely; position is 100% telecommuting.
• Must possess excellent communication skills (written, verbal) and facility with MS Office suite programs (word, PowerPoint, excel, etc.)

Must be a US Citizen or Full Green Card holder.