Biocompatibility Scientist

529-QA Sr. Staff        ·          Aliso Viejo, California, USA          ·         Full time

Job ID: 11441BR
Job Title: Biocompatibility Scientist
Location: Aliso Viejo, California, USA
529-QA Sr. Staff

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

Job Description

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.

Qualifications

• 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).

Desired Qualifications

• 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.

Posting Country: US – United States

Please click here to apply.