, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Experience in supporting...
(such as ISO 9001/13485, FDA 21 CFR part 820, and IVD/MDD directives). Serve as the primary representative for software quality...
, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Experience in supporting...
and presentations. A working knowledge of GMP, ISO 13485 & MDD requirements. Requisition ID: 599496 The anticipated annualized...
control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC... of applicable medical device regulations and standard such as ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93/42...
management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures. Ensure the systematic...
in medical device/pharma industry. Experience to include ISO 13485, 21 CFR 820, MDD 93/42/EEC, EU MDR 2017/745, and MDSAP...
of results, and generate detailed technical reports. Provide support to project teams in the compliance of ISO13485, MDD / MDR...
management, including FDA QSR, MDD, EU MDR, CMDR, ISO 13485, ISO 14971, and Philips procedures. - Ensure the systematic...
resolution skills Specialized Knowledge: o Knowledge of current FDA, ISO, MDD, and other related quality and regulatory system...