Vacancy expired!
Apex Systems is looking to hire for Fully Remote Biocompatibility Specialists! For immediate consideration please send an updated copy of your resume to Megan at with "Biocompatibility Specialist" in the subject line Title: Biocompatibility Specialist Location: Remote Length: Long term renewable contract Hours: Normal business hours (EST) Job Description:
- Review, plan and perform Biocompatibility assessments and assure biosafety-related information and ensure data is accurate, reliable, and supports business objectives as consistent with the Global Toxicology / Biocompatibility Organization objectives
- Demonstrate a primary commitment to patient safety and product quality and a focus on Orthopedics.
- Provide inputs to testing strategy, write and approve Biocompatibility Assessments and reports and assess test data
- Strategize testing plans to meet project deliverables and schedules. Provide guidance on evaluations related to new investigational and strategic device development programs. Provide guidance on evaluations related to product changes throughout the product lifecycle.
- This position serves as a major resource for biosafety and toxicology information for medical devices and materials, which may include issues related to colorant additives, solvents, metals, and other hazardous chemicals.
- Provide consultation and guidance on biocompatibility and toxicological issues, support problem solving and resolution.
- Must be able to communicate effectively at all levels within Biocompatibility as well as cross-functionally with departments such as Product Development, Regulatory, Manufacturing, and Quality.
- Experience working with geographically dispersed teams
- Knowledge of biocompatibility evaluations (ISO 10993-1) for medical devices and drug-device combination products.
- Experience with toxicology assessments of leachables and extractables of medical device materials
- Applied knowledge and understanding of toxicology principles and best practices, regulatory standards, and requirements in the context of business activities.
- Good knowledge on Design control and management process as per ISO 13485.
- This candidate must be able to communicate effectively at all levels cross-functionally with departments such as PD, Regulatory, Manufacturing, and Quality.
- MS or PhD in Toxicology with 3-4 years of experience in Medical devices.
- Must be able to review and perform Biocompatibility assessments for Medical Devices.
- Write and approve Biocompatibility assessments and reports.
- Review and perform risk assessments based on patient contact for Medical devices.
Vacancy expired!