NAMSA in
Study Director | NAMSA | Future Openings (Finance)
NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. Since 1976, NAMSA has been testing medical devices, even before the U.S. Food and Drug Administration began regulating such products.
We are shaping the industry by contributing to the development of test methods that govern it. NAMSA has become the industry's premier provider, supporting clients throughout the product development lifecycle and beyond.
Join an organization with:
Vision:
to inspire innovative MedTech solutions that advance global healthcare, improve patient lives, and accelerate client success. Mission:
to deliver best-in-class global MedTech development solutions through our people, expertise, and technology by adhering to our core values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives, and ideas. Job Description: Assist in coordinating study conduct tasks from initiation to completion. Perform non-complex studies, serve as the primary client contact, and keep clients informed of schedules and issues. Ensure compliance with quality system regulations (ISO, GMP, GLP) and NAMSA SOPs. Understand Animal Welfare Requirements and serve as Principal Investigator when applicable. Serve as Study Director for GLP and non-GLP preclinical studies, ensuring GLP regulations are followed. Participate in study-specific procedures as needed. Evaluate, analyze, interpret data, and present scientifically sound reports. Ensure accurate recording, verification, and organization of data, including unanticipated responses. Archive study records for GLP studies upon completion. Interact with regulatory bodies (FDA, NMPA, ANSM, etc.) as necessary. Prepare protocol submissions for IACUC review and respond to comments/questions. Engage with clients, auditors, inspectors, subcontractors, and other stakeholders. Participate in client discussions on study design. Develop and lead moderately complex study designs, serve as the client contact, and keep clients informed of progress. Ensure schedule, budget, and quality commitments are met. Manage internal teams to meet client expectations. Understand investigational products and the Medical Device Development Process at a high level. Assist with departmental training as needed. Perform other duties as assigned. Qualifications & Technical Competencies: Bachelor's degree in a scientific discipline with at least two years' laboratory experience, or a Master's/PhD with at least one year of relevant experience. Working Conditions: Exposure to office conditions, laboratory animals, imaging equipment, chemicals, and BSL2 environments. Occasional exposure to zoonotic diseases and bloodborne pathogens. Moderate noise level; ability to sit, stand, lift up to 50 pounds, and perform visual tasks.
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to inspire innovative MedTech solutions that advance global healthcare, improve patient lives, and accelerate client success. Mission:
to deliver best-in-class global MedTech development solutions through our people, expertise, and technology by adhering to our core values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives, and ideas. Job Description: Assist in coordinating study conduct tasks from initiation to completion. Perform non-complex studies, serve as the primary client contact, and keep clients informed of schedules and issues. Ensure compliance with quality system regulations (ISO, GMP, GLP) and NAMSA SOPs. Understand Animal Welfare Requirements and serve as Principal Investigator when applicable. Serve as Study Director for GLP and non-GLP preclinical studies, ensuring GLP regulations are followed. Participate in study-specific procedures as needed. Evaluate, analyze, interpret data, and present scientifically sound reports. Ensure accurate recording, verification, and organization of data, including unanticipated responses. Archive study records for GLP studies upon completion. Interact with regulatory bodies (FDA, NMPA, ANSM, etc.) as necessary. Prepare protocol submissions for IACUC review and respond to comments/questions. Engage with clients, auditors, inspectors, subcontractors, and other stakeholders. Participate in client discussions on study design. Develop and lead moderately complex study designs, serve as the client contact, and keep clients informed of progress. Ensure schedule, budget, and quality commitments are met. Manage internal teams to meet client expectations. Understand investigational products and the Medical Device Development Process at a high level. Assist with departmental training as needed. Perform other duties as assigned. Qualifications & Technical Competencies: Bachelor's degree in a scientific discipline with at least two years' laboratory experience, or a Master's/PhD with at least one year of relevant experience. Working Conditions: Exposure to office conditions, laboratory animals, imaging equipment, chemicals, and BSL2 environments. Occasional exposure to zoonotic diseases and bloodborne pathogens. Moderate noise level; ability to sit, stand, lift up to 50 pounds, and perform visual tasks.
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