con las siguientes regulaciones: ISO , GMP, JPAL, CMDCAS, MDD, United States (21 CFR parts ), European Community (MDD/EEC), Canada...
Community (MDD/EEC) - Canada (Canadian Medical Device Regulations SOR/) - Brazil (ANVISA resolution RDC No., RDC (Class I, II...
and established Quality System standards (i.e., QSR, MDD, CMDCAS, ISO & ISO ****) - Able to view processes from a systems...
(i.e., QSR, MDD, CMDCAS, ISO & ISO ****). - Able to view processes from a systems perspective and interpret details that impact...
practices and FDA/QSR;ISO;CMDR;MDD medical device Directive regulations, MHLW ordinance 169 U.S. Applicants: EOE/AA...
Regulations and standards (e.g. QSR, ISO, EN, and Medical Device Directive (MDD) requirements, EU MDR) - Performs other duties... of regulatory compliance requirements (QSR, MDD, ISO ****, ISO, ISO and other international standards) is required - ASQ...
, Labor, and Welfare- Ordinance No. 169, ****) SOR/ (Canadian Medical Device Regulation) MDD /EEC (European Council...
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...