Senior Manufacturing Engineer - Shockwave Medical
requirements such as QSRs, FDA, ISO, MDD and other applicable regulations. Experience and understanding Process Validations (IQ,OQ...
requirements such as QSRs, FDA, ISO, MDD and other applicable regulations. Experience and understanding Process Validations (IQ,OQ...
with applicable regulatory requirements, including but not limited to U.S.FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA...
requirements in generating periodic PMS related reports Participate in projects to align with BD Quality, MDD/MDR strategies...
with applicable regulatory requirements, including but not limited to U.S.FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA...
regulations and standards. Working knowledge of QSR’s, ISO 13485, MDD, MDR, CMDR, and FDA requirements and standards. A working...
to regional Health authorities per FDA, MDD and MDR requirements. This includes the resolution of regulatory issues and questions... System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD...
and execution of meetings and presentations. A working knowledge of GMP, ISO 13485 & MDD requirements. Requisition ID: 598551...
challenges, including oppositional defiant disorder, ADHD, MDD, depression, and anxiety. The candidate will work with a team...
and execution of meetings and presentations. A working knowledge of GMP, ISO 13485 & MDD requirements. Requisition ID: 598551...
to identify, monitor and manage model risk. Responsible for model development documentation (MDD) for both in-house and vendor...