Expert Coach II
13485, Canadian Medical Device Regulation (CMDR), In Vitro Diagnostic Directive (IVDD), and Medical Device Directive (MDD...
13485, Canadian Medical Device Regulation (CMDR), In Vitro Diagnostic Directive (IVDD), and Medical Device Directive (MDD...
Job Title: Quality Systems Specialist Job Description In compliance with FDA, European MDD/MDR & ISO regulations...
documentation and organizational skills. Knowledge of the following regulations and standards: ISO13485, MDSAP, EU MDR/MDD...
required to participate in the Material Development Decision (MDD), the pre-/post-Acquisition Strategy Panel (ASP), source selection activity...
. pre-submissions, 510(k)s, EU MDD/MDR and MDSAP documentation, Design Control, Risk Management, Usability, Technical...
of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations...
of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations...
Device Directive (MDD)/ Medical Device Regulation (MDR), and applicable guidance. Provide Quality representation... 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA's General Principles of Software validation...
such as QSRs, FDA, ISO, MDD and other applicable regulations. Experience and understanding Process Validations (IQ, OQ, PQ), 6S...
, and opportunities Expert knowledge of ISO, FDA, MDD and regulations applicable to the design and development of medical device/science...