Principal Toxicologist

Position Overview

Serves as a subject matter expert (SME) for MicroVention (MVI), particularly in the application of ISO 10993 to biocompatibility testing and chemical characterization risk assessments of medical devices and combination products. Job duties:
  • Devise and implement biocompatibility testing strategies for medical devices and combination products.
  • Manage the company’s ISO 10993 biocompatibility testing with contract laboratories.
  • Write toxicological risk assessments based on chemical characterization of medical device extracts.
  • Write internal documentation, including test protocols, test reports, justifications, and other documents.
  • Effectively collaborate with multi-functional product development teams to achieve timely project outcomes.
  • Serve as a SME on biocompatibility and toxicological issues, support problem solving and resolution. This may include issues related to metals and chemical residuals.
  • Support the toxicological aspect of the company’s regulatory submissions worldwide.
  • Ensure that the company’s toxicological testing meets all domestic and international requirements per ISO, FDA, ICH, and GLP guidelines.
  • Performs additional responsibilities as assigned.

Job Details

Job ID 11441BR

Aliso Viejo, California, USA

Salary Range:

$115,000 - $160,000 (Compensation can vary based on education, experience and skill sets)

    1. PhD or equivalent combination of education and experience in toxicology or related field (forensics, pharmacology etc.).
    2. Minimum five (5) to eight (8) years of experience at a Principal job level.
    3. Minimum five (5) to eight (8) years of experience in medical device toxicology.
    4. Strong experience in the application of ISO 10993-1 and ISO 10993-17.
    5. Solid experience with in vitro and in vivo models of biocompatibility assessment.
    6. Strong experience in chemical characterization risk assessments is required.
    7. Solid expertise in relevant toxicological standards (ISO, FDA, ICH).
    Desired Qualifications
    1. DABT (Diplomate of the American Board of Toxicology) certification preferred.
    2. Demonstrated ability to work individually and as a team member, with minimal supervision.
    3. Demonstrated ability to achieve goals within the timeline and budget.
    4. Effective written and verbal communication skills.
    5. Intermediate computer skills including Excel and Word.