Clinical Research Coordinator, MS. Degree in Science, Statistics, Management or related & 1 year experience: Internal/external audits to ensure firm is compliant with ISO 13485 & 21 CFR. Experience in CAPA & Nonconformance to product through product data analysis. Make design changes in Enable/Agile & Wind-chill to close it through the global review board. Knowledge of compliance W/all regulatory & local regulations including US-FDA Pre-market approval, 510K submissions & Supplements. Verify & validate Diabetes insulin pumps per IEC 60601-2-24. Work on CAD/CAE Solid works tools & maintain CAD doc. & customized CAD program. Work on Design Controls, Prod. Life Cycle Management, Systems Architecture & Simulation based Product Development. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US.
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