Raynham Raynham, MA 02767
Job Title: Toxicologist
Location: Raynham, MA - 02767
Duration: 12+ Months
About Our Client : Our Client is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Our Client works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Our Client drives innovation to improve the way the world works and lives
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.
- 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 of testing related to new investigational and strategic device development programs.
- 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 Bio-compatibility as well as cross-functionally with departments such as PD, 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.
- MS or PhD in Toxicology, Biology, Biochemistry or Biomedical.
About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities
Leah Sunkara @ Leahs@askstaffing.com ; - 678-250-9922