selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents...
/MDD, RED, LVD, RoHS, etc.) and Canadian licensing submissions according to international guidelines. Maintains expertise... on the US (FDA), EU (MDD), and CA (Health Canada). You're the right fit if: Formulates the solution for (technical...
, and/or efficiencies. Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, and ISO 13485...
, and/or efficiencies. Requires background and familiarity with U.S. FDA QSR, requirements including ISO 9001, MDD 93/42, and ISO 13485...
, MDD, MDR Knowledge of IVDD, IVDR and/or 3P510K is preferrable. Minimum 3 year managing experience in auditing...
, MDD, MDR Knowledge of IVDD, IVDR and/or 3P510K is preferrable. Minimum 3 year managing experience in auditing...
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...
, MDD, Eudralex, other global or regional equivalent Working knowledge of US and International cGMP as it applies to the...