Toxicologist

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

📋 Description

• Engage in discussions with potential clients.

• Provide project scope and pertinent information to assist in proposal development.

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

• Prepare risk assessments, evaluation plans, and reports in accordance with ISO 10993-1, ISO 10993-17, and ISO 14971 for submissions to the FDA and other regulatory bodies.

• Assess and summarize biocompatibility and general toxicology data to ensure adherence to relevant regulatory standards.

• Ensure that biocompatibility studies comply with the latest regulatory requirements.

• Offer technical support to laboratory personnel.

• Provide clients with guidance on technical matters concerning biocompatibility and material characterization.

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

• Conduct and summarize literature reviews.

• Coordinate the collection of test data from other NAMSA departments for specific projects.

• Set and ensure adherence to schedules, budgets, and quality commitments for clients.

• Assess and interpret the biological relevance of unexpected findings.

• Comprehend investigational products and the Medical Device Development Process.

• Manage challenging situations and recognize when to seek assistance.

• Interact with clients, auditors, inspectors, subcontractors, consultants, and various departments.

• Write blog entries or white papers.

• Summarize testing reports for submissions.

• Identify and assess applicable Standards and Guidance Documents for clients’ devices.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor's degree or equivalent experience in a relevant field, with a minimum of 5 years of pertinent experience; or a Master's or Doctorate degree with a minimum of 2 years of relevant experience.

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

• Familiarity with applicable standards and regulations governing medical devices.

• Ability to evaluate compliance of biocompatibility and material characterization results with relevant standards and regulations.

• Capability to create biological safety documents and reports that meet applicable standards and regulations.

• Knowledge of and experience with Microsoft Word.

• Skills in writing and reviewing complex documents.

• Working knowledge of FDA medical device regulations and/or biologics regulations, ISO 10993 series, and ISO 14971.

• Occasional travel may be necessary.

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

• Regular use of telephone and video conferencing tools.

• Extensive use of computer keyboard and mouse; prolonged periods of sitting.

🏝️ Benefits

• Reasonable accommodations for individuals with disabilities.

• Pre-employment background checks and drug screening processes adhere to local, state, and federal laws.