Principal, Global Quality Compliance: External Regulatory Communication - Remote
, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Experience in supporting...
, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Experience in supporting...
, metrics, reporting and operating mechanisms. Hands-on experience with FDA, QSR, ISO, MDD, GDP, GLP, GMP and/or other local...
). Minimum of 3 years of experience in quality and risk management in a highly regulated industry. Familiarity with FDA, ISO, MDD...
, including Know Your Member (KYM) requirements, member due diligence (MDD) requirements, Member Identification Program (MIP... controls to management to ensure risk mitigation. (25%) 2)Analyzes and investigates MDD/EDD triggered alerts including...
Demonstrated knowledge of US and foreign QMS requirements, including but not limited to FDA cGMP, EU MDD/MDR, Canadian MDR...
and/ or are under-resourced Psychologist will treat SUD, adjustment disorders, grief, ODD, MDD, GAD, BPD, schizophrenia, and schizoaffective...
, MDSAP, MDD and MDR standards. The Sr. Medical Device Auditor is responsible to make relevant decisions concerning the audit... such as MDSAP, MDD, MDR and EU. In performing the duties described above, to ensure that such duties are performed in an efficient...
) 3 years of experience with FDA or PMDA Quality System Requirements (QSRs), ISO 13485, or MDD 93/42/EEC;4) 3 years...
of GMP, ISO 13485 & MDD requirements. #LinkedIn Remote Requisition ID: 599879 The anticipated annualized base amount...
. Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable...