Principal, Global Quality Compliance: External Regulatory Communication
requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Fluent in...
requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Fluent in...
requirements, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Fluent in...
but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Experience working in a global organization...
challenges, including oppositional defiant disorder, ADHD, MDD, depression, and anxiety. The candidate will work with a team...
required to participate in the Material Development Decision (MDD), the pre-/post-Acquisition Strategy Panel (ASP), source selection activity...
applications (Word, Excel, PowerPoint, Project, etc), and experienced work in a Quality Management System and UDI/MDD/MDR/UKCA...
international regulations (e.g. 820, MDD, ISO, and other countries). Complete all required customer complaint related documentation...
, or other quality managed industries. Working knowledge of applicable regulations, such as FDA QSR, ISO, MDD, &/or IVDD...
, ISO13485. Risk Management techniques and experience in EN 14971, EN IEC 60601-1/-2, EN IEC 62304, MDD / MDR Essential...
understanding of 21CFR211 – cGMP, 21CFR820 - QSR, ISO 13485, Canadian MDR, MDD-93/42 with emphasis on laboratory testing, material...