Toxicologist III in Alpharetta, GA at Tech Providers Inc

Date Posted: 5/24/2021

Job Snapshot

Job Description

Position Title: Toxicologist III

Location: Alpharetta, GA

Expected Duration of Project: 12  months

Experience:

Serve as the primary Global Product Safety (GPS) lead on project teams for the research, development, global regulatory submissions and commercialization of medical device products as well as being responsible for timely product safety-related activities required to support existing products and due diligence and integration activities to support Merger & Acquisitions General Expectations and Accountabilities:

•         Actively partner with cross-functional product development teams and serve as primary product safety liaison for assigned projects to support research and development, global regulatory submissions and commercialization.

•         Effectively author and communicate toxicology information and human health risk assessments to internal and external technical experts as well as program managers.

•         Support the product safety activities for life-cycle management of existing products.

•         Provides technical leadership in solving challenging technical problems related to product safety issues.

•         Support external and internal regulatory compliance audits. Position Specific Accountabilities: Lead and/or manage the design, monitoring and interpretation of in vitro / in vivo toxicology or clinical safety studies conducted under ISO 10993 Guidelines and Good Laboratory Practices (GLP). Author, document and communicate human health safety (risk) assessments taking into consideration identified hazard and patient or user exposure according to intended product use or foreseeable misuse. Conduct safety and exposure assessments for Avanos products to support global regulatory compliance related to chemicals of concerns. Provide product safety support for Due Diligence and Integration for Mergers and Acquisitions (M&A) activities.

Required Qualifications:

•         Degree in toxicology, biomedical or related field of relevant product safety experience in the design, development, regulatory clearance/approval and maintenance of medical devices in global markets; o Bachelor’s degree with 10-15 + years of experience, or o Master’s degree with 5-10 + years of relevant experience, or o Ph.D., M.D., or D.V.M. with 3-10 +years of relevant experience.

•         Proficient knowledge in regulatory science and quality management system requirements associated with the development, commercialization and manufacture of medical device in global markets.

Preferred Qualifications:

•         Certification by the American Board of Toxicology (DABT) or other equivalent health science or medical professional certification is highly desirable.