International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System as an overall management system...
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...
(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission/amendments...
preferred with an in-depth understanding of (GMP/QSR/ISO/MDD/MDR) regulations a plus, with focus on inspection points...
Opportunities: The Market Development Manager reports to MDM Lead with dotted line responsibility to MDD. The MDM will interact...
; Experience and knowledge of Canadian Medical Device Regulations, MDD, MDSAP and ISO standards preferred; Minimum of three years...
but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Experience working in a global organization...
requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Fluent in...