Toxicologist
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Job Description
Toxicologist preparing biocompatibility and toxicology assessments for NAMSA’s medical-device clients. Developing regulatory reports, advising clients, and supporting FDA submissions.
Responsibilities:
- Participate in meetings with prospective clients
- Provide project scope and relevant information to support proposal creation
- Offer clients opportunities to expand services provided by NAMSA
- Prepare risk assessments, evaluation plans, and reports compliant with ISO 10993-1, ISO 10993-17, and ISO 14971 for FDA and other regulatory submissions
- Evaluate and summarize biocompatibility and general toxicology data for regulatory compliance
- Ensure biocompatibility studies comply with current regulatory requirements
- Provide technical support to laboratory staff
- Advise clients on biocompatibility and material characterization issues
- Perform biocompatibility gap analyses and write clear, concise reports
- Perform and summarize literature searches
- Facilitate collection of project-related test data from other NAMSA entities
- Ensure client schedule, budget, and quality commitments are met
- Evaluate the biological relevance of unexpected results
- Understand investigational products and the Medical Device Development Process
- Interact with clients, auditors, inspectors, subcontractors, consultants, and internal departments
- Author blog posts or white papers
- Summarize testing reports for submissions
- Identify and evaluate standards and guidance documents applicable to clients’ devices
- Handle challenging situations and seek assistance when needed
- Perform other duties as assigned
Requirements:
- Bachelor’s degree or equivalent experience in a related field, and a minimum of 5 years of relevant experience; or Masters or Doctorate degree, and a minimum of 2 years of relevant experience required
- Fluency in English and local language, if different, required
- Knowledge and experience with applicable standards and regulations for medical devices
- Ability to assess/audit compliance of biocompatibility and material characterization results to applicable standards and regulations
- Ability to develop biological safety documents and reports compliant with applicable standards and regulations
- Knowledge of and experience with Microsoft Word
- Ability to write and review complex documents
- Ability to talk or hear; frequently stand, walk, sit, use hands to finger, handle, or feel, and reach with hands and arms
- Ability to occasionally lift and/or move up to 50 pounds (23 kgs)
- Frequent use of telephone and video conferencing tools
- Extensive use of computer keyboard and mouse; prolonged periods of sitting
Benefits:
- Equal employment opportunity
- Pre-employment background and drug screen processes aligned to local, state and federal laws
- Reasonable accommodations for individuals with disabilities
- Occasional travel may be required
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