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...
Senior Technical Lead - MDR, ISO 13485, MDD United States Job Description Senior Technical Lead - MDR, ISO 13485..., MDD Hamilton,Ohio Job Summary As a Senior Technical Lead specializing in mdr,ISO 13485, and mdd, the primary...
’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...
Matter Expert (SME) on design control and risk management processes, including FDA 21 CFR 820.30, FDA guidance, European MDD... (electrical, mechanical, optical, software) Design control for medical devices development (21 CFR 820.30, ISO 13485, MDD/MDR...