but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Experience working in a global organization...
but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Experience working in a global organization...
of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD. Understanding of the interdependencies of program work...
(Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA. Strong working knowledge of EU (MDD / MDR) medical device...
(Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA. Strong working knowledge of EU (MDD / MDR) medical device...
. Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD. Understanding of the interdependencies...
management System, ISO 14971:2019 Risk Management, Directive (ED)93/42/EEC (MDD) European Union Medical Device Directive...
Systems Regulation, ISO 14971, MDD 93/42/EEC, EU MDR, and other relevant international laws. Outstanding problem-solving...
Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC) Understanding of Risk Management in accordance...
Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC) Understanding of Risk Management in accordance...