NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.
We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.
Come and work for an organization with the:
Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the
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:
• Reviews raw data generated by laboratory studies for technical accuracy and completeness.• Makes approved changes to documents (SOP’s, protocols, worksheets, reports).
• Reviews related documents for consistency and regulatory compliance.
• Provides clerical/administrative assistance to assigned staff
• Generates IACUC submissions
• Keeps study spreadsheets/catalogs up to date
• Reviews study photos and transfers to digital media
• Responsible for meeting on-time metrics.
• Assists with special protocol and worksheet development.
• Handles challenging situations, and knows when to call-in help.
• Interacts as needed with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments.
• Initiates nonconformance discovered during data review.
• Assists management with scheduling activities
• Other duties as assigned.
Qualifications & Technical Competencies:
• Associate’s degree in a scientific discipline with 1 year laboratory experience or at least 4 years relevant experience.
• AALAS (ALAT, LAT, or LATG) certification recommended.
• Fluency in English and local language, if different, required.
• Knowledge of statistics and metric system, strong computer skills.
Working Conditions:
• Physical activities include sitting, walking, using hands to finger, handle or feel, and reaching with hands and arms.
• Vision abilities include close vision, color vision, and ability to adjust focus.
• Physical requirements include being able to frequently move or lift up to 25 pounds.
• Employee must be able to talk and hear.
Skills Required
- Associate's degree in a scientific discipline with 1 year laboratory experience or at least 4 years relevant experience
- AALAS (ALAT, LAT, or LATG) certification
- Fluency in English and local language, if different
- Knowledge of statistics and the metric system
- Strong computer skills
- Ability to frequently move or lift up to 25 pounds; adequate vision, hearing, and speech
What We Do
Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes. Learn more: https://namsa.com/about/client-testimonials
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