International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System as an overall management system...
or biopharmaceutical environment. Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR...
as well as those of our customers and the ISO 13485 International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System...
develop comprehensive regulatory strategies relating to PMA, IDE, ''510(k) premarket notifications, EU MDD Technical File/MDR...
. Knowledge of metrology. Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO...
and External Audits as required. Ensure compliance with ISO 13485, MDD, 21 CFR 820, GMP, and other applicable regulations...
authoring EU Clinical Evaluation Plans and Reports (CEP, CER) in compliance with applicable regulations and guidance (MDD, MDR...
. Knowledge of metrology. Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, ISO...
-1:9, our unit treats a variety of diagnoses such as Major Depressive Disorder (MDD), Bipolar Disorder, Schizophrenia...
interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, MDD...