
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.
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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.
• Participate in meetings with prospective clients • Provide scope of project and relevant information to support proposal creation • Offer clients opportunities for expansion of NAMSA services • Prepare risk assessments, evaluation plans, and reports in compliance 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 test data from other NAMSA entities for specific projects • Ensure schedule, budget, and quality commitments are met • Evaluate the biological relevance of unexpected results • Understand investigational products and the Medical Device Development Process • Handle challenging situations and escalate when needed • 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
• 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 • 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 • Occasional travel may be required
• Reasonable accommodations for individuals with disabilities • Equal employment opportunity • Pre-employment background and drug screen processes aligned to local, state and federal laws
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