and Skills: Quality Management Systems requirements for medical devices Knowledge and applied experience of 21CFR, MDD 93/42...
Systems Regulations, MDSAP, ISO 13485 & 9001, ISO 14971, EU MDD/IVD, EU MDR/IVDR, SOR/98-282, TG(MD)R, RDC 16, Ordinance #169...
such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards. Expert knowledge of GMP, GDP procedures...
’s (SSP), Multi-Department Direction’s (MDD), and Single Department Direction’s (SDD). * As a SSW you will maintain...
, MDD, JPAL and CMDR. Ensures that product acceptance activities are handles in a manner that complies with all pertinent...
., FDA 510(k), PMA, CE Mark). In-depth knowledge of global medical device regulations (e.g., FDA regulations, MDD/MDR...
customized components Familiarity with the medical device Regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues...
’s (SSP), Multi-Department Direction’s (MDD), and Single Department Direction’s (SDD). * As a SSW you will maintain...
, ISO13485, MDD and Country-Region regulations). Monitors, manages and reports on quality metrics for assigned shifts/lines...
such as GMPs, ISO 13485/9001, and the MDD. Familiar with Design Control procedures and requirements. Excellent written and verbal...