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