and execution of meetings and presentations. A working knowledge of GMP, ISO 13485 & MDD requirements. Requisition ID: 598551...
and interpretation of applicable regulations, guidelines and policy statements (QSR, MDD, and ISO) Excellent written and oral...
to identify, monitor and manage model risk. Responsible for model development documentation (MDD) for both in-house and vendor...
supplier audits to evaluate QMS and regulatory compliance in accordance with FDA regulations, ISO13485, MDSAP, MDD/MDR...
and immediate consumption channels of business. (RVP, TSL, MDM, NAE, RAE, MDD, DSS etc.) Own timely sharing of volume & share...
in line with ISO 13485, Medical Device Directive (MDD), Medical Device Regulation (EU-MDR), MDSAP International Regulations... Quality System compliance to ISO 13485, MDD, EU-MDR, MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA...
quality, safety, health and environment systems continue to meet FDA, ISO, MDD, CMDCAS, EPA, OSHA and other appropriate...
+ years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, PMDA, TGA...
and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards). Knowledge / Experience developing ways of accomplishing goals...
/ MDD / CE, IEC 62304 / 62366, Design Controls / Design History File, Requirements Definition, Risk Management, Validation...