Quality Management System, ISO 149721:2019, Risk Management, Directive (ED)93/42/EEC (MDD) European Union Medical Device...
company’s Design Control requirements and consistent with FDA, ISO, and MDD requirements. Participate on cross-functional...
EU Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) Ability to work effectively...
Systems Regulations, including GMP, ISO, FDA, MDSAP, and MDD/MDR. Working knowledge of statistical methods and related...
, and the MDD Familiar with Design Control process Excellent written and verbal communication skills Proficiency...
responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation...
, etc. You have strong understanding of Medical Device regulations/standards including ISO 13485/14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR, cGMP...
regulations/standards including ISO 13485, ISO 14971, 21CFR (803, 806, 820, etc.), MDD/ EU MDR. You’re able to analyze quality...
and Medical Device Domain (MDD). 5+years of working experience in managing Critical Manufacturing MES implementations...
with FDA regulations, ISO13485, MDSAP, MDD/MDR and other applicable global regulatory requirements for manufacturers...