Toxicologist

🔥 22 hours ago

🇺🇸 United States – Remote

💵 $83.5k - $162.9k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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NAMSA

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1967

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

Healthcare • Manufacturing • Logistics

NAMSA is a global leader in medical device testing and research, offering comprehensive consulting, preclinical research, clinical research, and testing services for medical device and IVD manufacturers worldwide. With a team of over 1,400 specialists and state-of-the-art labs across North America, Europe, and Asia, NAMSA conducts extensive testing to ensure the safety, efficacy, and compliance of medical devices. The company provides strategic consulting on regulatory submissions and market strategies, helping clients navigate complex regulatory landscapes efficiently and effectively. Founded in 1967, NAMSA is trusted by manufacturers to deliver high-quality services from concept to commercialization.

📋 Description

• Participate in meetings with prospective clients • Provide scope of project and relevant information to support the creation of proposals • Offer opportunities to clients for expansion of services to be provided by NAMSA • Prepare risk assessments, evaluation plans and reports, in compliance with ISO 10993-1, ISO 10993-17 and ISO 14971, for submissions to FDA and other regulatory agencies • Evaluate and summarize biocompatibility and general toxicology data ensuring compliance with relevant regulatory requirements and standards • Ensure biocompatibility studies are in compliance with the most recent regulatory requirements • Provide technical support to lab staff • Advise clients on technical issues related to biocompatibility and material characterization • Perform biocompatibility gap analyses and write clear, concise reports • Perform and summarize literature searches • Facilitate collection of test data from other NAMSA entities for specific projects • Establish and ensure schedule, budget and quality commitments are met for clients • Evaluate and determine biological relevance of unexpected results • Understand investigational products and the Medical Device Development Process • Handle challenging situations and know when to call in help • Interact with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments • Author blog posts or white papers • Summarize testing reports for submissions • Identify and evaluate Standards and Guidance Documents applicable to clients’ devices • 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 that are compliant with applicable standards and regulations • Knowledge of and experience with Microsoft Word • Write and review complex documents • Working knowledge of FDA medical device regulations and/or biologics regulations, ISO 10993 series, and ISO 14971 • Occasional travel may be required • 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

• Reasonable accommodations for individuals with disabilities • Pre-employment background and drug screen processes aligned to local, state and federal laws