Associate 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 creation of proposals.

• Present clients with opportunities to expand their use of NAMSA services.

• Prepare risk assessments, evaluation plans, and reports that adhere to ISO 10993-1, ISO 10993-17, and ISO 14971 for FDA and other regulatory submissions.

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

• Guarantee that biocompatibility studies align with current regulatory standards.

• Provide technical assistance to laboratory personnel.

• Advise clients on matters related to biocompatibility and material characterization.

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

• Execute and summarize literature searches.

• Facilitate the collection of test data from other NAMSA divisions for specific projects.

• Ensure that schedule, budget, and quality commitments are fulfilled.

• Evaluate the biological significance of unexpected results.

• Comprehend investigational products and the Medical Device Development Process.

• Manage challenging situations and escalate issues as necessary.

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

• Write blog posts or white papers.

• Summarize testing reports for submission purposes.

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

• Perform additional duties 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, accompanied by at least 2 years of relevant experience is required.

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

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

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

• Ability to develop biological safety documents and reports that comply with relevant standards and regulations.

• Proficient in Microsoft Word.

• Skilled in writing and reviewing complex documents.

• Ability to communicate verbally and audibly; regularly stand, walk, sit, use hands to 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.

• Occasional travel may be required.

🏝️ Benefits

• Reasonable accommodations for individuals with disabilities.

• Equal employment opportunity.

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