Toxicologist

This is a fully remote position, open to applicants in United States.

📋 Description

• Engage in discussions with potential clients.

• Supply project scope and pertinent information to assist in the development of proposals.

• Present clients with opportunities to enhance services offered by NAMSA.

• Create risk assessments, evaluation plans, and reports that comply with ISO 10993-1, ISO 10993-17, and ISO 14971 for FDA and other regulatory submissions.

• Analyze and summarize biocompatibility and general toxicology data to ensure regulatory compliance.

• Confirm that biocompatibility studies adhere to current regulatory standards.

• Provide technical assistance to laboratory personnel.

• Counsel clients on issues related to biocompatibility and material characterization.

• Conduct biocompatibility gap analyses and produce clear, concise reports.

• Execute and summarize literature reviews.

• Facilitate the collection of project-related test data from various NAMSA entities.

• Ensure that client schedules, budgets, and quality commitments are fulfilled.

• Assess the biological significance of unexpected outcomes.

• Comprehend investigational products and the Medical Device Development Process.

• Communicate with clients, auditors, inspectors, subcontractors, consultants, and internal teams.

• Write blog posts or white papers.

• Condense testing reports for submissions.

• Identify and assess standards and guidance documents relevant to clients’ devices.

• Manage challenging situations and seek help when necessary.

• Carry out other tasks as assigned.

⛳️ Requirements

• A Bachelor’s degree or equivalent experience in a related field, with a minimum of 5 years of relevant experience; or a Master’s or Doctorate degree, with at least 2 years of relevant experience required.

• Proficiency in English and the local language, if different, is essential.

• Familiarity and experience with applicable standards and regulations for medical devices.

• Capacity to evaluate/audit compliance of biocompatibility and material characterization results against applicable standards and regulations.

• Ability to create biological safety documents and reports that meet relevant standards and regulations.

• Proficient in Microsoft Word.

• Competence in writing and reviewing complex documents.

• Capability to communicate verbally; frequently stand, walk, sit, use hands to manipulate objects, and reach with hands and arms.

• Ability to occasionally lift and/or move up to 50 pounds (23 kgs).

• Regular use of telephone and video conferencing tools.

• Extensive use of a computer keyboard and mouse, including prolonged periods of sitting.

🏝️ Benefits

• Equal employment opportunity.

• Pre-employment background checks and drug screening processes in accordance with local, state, and federal laws.

• Reasonable accommodations for individuals with disabilities.

• Occasional travel may be necessary.