36 months in the following FDA QSR 21 CFR 820, ISO 134852016, ISO 14971, MDSAP, CE Marking; Global qualityregulatory requirements for USFDA, EU Notified Bodies, Health Canada, Japans PMDA, Brazils ANVISA, Australias TGA; Hosting and managing regulatory auditsinspections, and representing medical device organizations to global regulatory agencies; Quality auditing certification such as ASQ and regulatory training in CAPA, Design Controls, Risk Management, Inspection Readiness, Supplier Controls, Proactive regulatory monitoring, and lobbying; and working in the global Medical Device Landscape to assure corporate compliance to all markets. Continued from H.10B job title of the acceptable alternate occupation Director, Quality Systems, Global Audit Manager, Sr. ComplianceAudit Specialist, International Regulatory Affairs Specialist, Junior Project Manager or related titles.

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