designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD. Familiar with GMP, GDP procedures...
Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR requirements Excellent computer...
or biopharmaceutical environment Must be familiar with FDA’s GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR...
working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD. Familiar...
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...
investigation compliance with the Food and Drug Administration (FDA), European Union Medical Device Directive (MDD), European Union...
. This position must ensure that all activities will be conducted in accordance with Government Regulations (FDA, MDD... for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations. Ensure identification...
setting; Knowledge of QSRs & ISO 13485; IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR. Salary Range: $90k-$120k...
. This involves assuring quality standards (FDA, ISO, CMDCAS, MDD, MDR, MDSAP and Canadian Medical Device requirements... Other duties may be assigned, in addition to those identified below Ensures FDA QSR (GMP), FDA OTC, ISO 13485, MDD, CMDCAS, MDR...