Toxicologist

🕒 il y a 6 jours

🇺🇸 États-Unis – Télétravail

💵 $83 500 - $162 900 / an

⏰ Temps Plein

🟢 Junior

🟡 Intermédiaire

👻 Score fantôme 0%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of NAMSA

NAMSA

1001 - 5000 employés

Fondée en 1967

🏥 Santé

🏭 Fabrication

📦 Logistique

Healthcare • Manufacturing • Logistics

NAMSA est un leader mondial dans le domaine des tests et de la recherche sur les dispositifs médicaux, offrant des services complets de conseil, de recherche préclinique, de recherche clinique et de tests aux fabricants de dispositifs médicaux et de diagnostic in vitro (IVD) dans le monde entier. Avec une équipe de plus de 1 400 spécialistes et des laboratoires à la pointe de la technologie en Amérique du Nord, en Europe et en Asie, NAMSA effectue des tests approfondis pour garantir la sécurité, l'efficacité et la conformité des dispositifs médicaux. L'entreprise fournit des conseils stratégiques sur les soumissions réglementaires et les stratégies de marché, aidant les clients à naviguer efficacement et efficacement dans des environnements réglementaires complexes. Fondée en 1967, NAMSA est un partenaire de confiance pour les fabricants, leur offrant des services de haute qualité de la conception à la commercialisation.

Description

• Participate in meetings with prospective clients • Provide project scope and relevant information to support proposal creation • Offer clients opportunities to expand services provided by NAMSA • Prepare risk assessments, evaluation plans, and reports compliant 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 project-related test data from other NAMSA entities • Ensure client schedule, budget, and quality commitments are met • Evaluate the biological relevance of unexpected results • Understand investigational products and the Medical Device Development Process • Interact with clients, auditors, inspectors, subcontractors, consultants, and internal departments • Author blog posts or white papers • Summarize testing reports for submissions • Identify and evaluate standards and guidance documents applicable to clients’ devices • Handle challenging situations and seek assistance when needed • Perform other duties as assigned

🎯 Exigences

• 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 compliant with applicable standards and regulations • Knowledge of and experience with Microsoft Word • Ability to 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

🏖️ Avantages

• Equal employment opportunity • Pre-employment background and drug screen processes aligned to local, state and federal laws • Reasonable accommodations for individuals with disabilities • Occasional travel may be required

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