Manager, Optics & Methods
, FDA, MDD and regulations applicable to the design and development of medical device/science/technology. Encounters...
, FDA, MDD and regulations applicable to the design and development of medical device/science/technology. Encounters...
, validation, and manufacturing. Exceptional verbal and written communication skills. Familiarity with ISO 13485, MDD, and FDA...
regulations Knowledge on Medical Device Regulatory Standards, MDD and MDR Knowledge on NC, CAPA, Audit processes Knowledge in...
International Standard, CMDCAS, FDA, and MDD regulations. We operate the Quality System as an overall management system...
Surveillance• Knowledge on Medical Device Regulatory Standards, MDD and MDR• Knowledge on NC, CAPA, Audit processes• Medical...
Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards...
(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission/amendments...
13485, EU MDD and 21 CFR 820) to avoid and resolve issues with CAPA, product recalls and external audits. Demonstrated...
preferred with an in-depth understanding of (GMP/QSR/ISO/MDD/MDR) regulations a plus, with focus on inspection points...
Opportunities: The Market Development Manager reports to MDM Lead with dotted line responsibility to MDD. The MDM will interact...