. Conocimientos básicos de licenciamiento. - Manejo de cuota entre los 500 K ´s y 1.0 MDD, experiência en manejo de márgenes...
de los requisitos reglamentarios, p. gramo. MDR, MDD /EEC) y otros requisitos relacionados** - Conocimiento sólido en productos... y organizar el trabajo - Dominio de MS Office - Sentido común y pragmatismo ** Auditor según ISO y MDR/MDD/AIMDD/MDSAP...
both with the company's quality control requirements as well as with the Regulations of: ISO , GMP, CMDCAS, MDD, United States (21... CFR parts ), European Community (MDD / EEC), Canada (Canadian Medical Device Regulations SOR / ), Brazil (ANVISA...
of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.). Skills: The following...
compliance to all applicable regulations and standards (US CFR, ISO13485, CMDR, MDD, JPAL). Serves as primary liaison... for manufacturing facility Coordinates the management of quality systems and applicable certifications (US CFR, ISO13485, CMDR, MDD...
) Strong working knowledge of QSR, ISO, MDD/MDR, Risk Management, and Canadian Medical Device requirements preferred. Demonstrate...