of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD, TGA etc.) Proficient in...
as well as those of our customers and the ISO 13485 International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System...
, validation, and manufacturing. Exceptional verbal and written communication skills. Familiarity with ISO 13485, MDD, and FDA...
, FDA, MDD and regulations applicable to the design and development of medical device/science/technology. Encounters...
International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System as an overall management system...
Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards...
(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission/amendments...
Surveillance• Knowledge on Medical Device Regulatory Standards, MDD and MDR• Knowledge on NC, CAPA, Audit processes• Medical...
regulations Knowledge on Medical Device Regulatory Standards, MDD and MDR Knowledge on NC, CAPA, Audit processes Knowledge in...
13485, EU MDD and 21 CFR 820) to avoid and resolve issues with CAPA, product recalls and external audits. Demonstrated...