such as MEDDEV and MDD/MDR is required, as well as other global requirements for clinical evaluation and PMS/PMCF. The Senior Medical..., emotional intelligence, flexibility Extensive knowledge of MDD, MDR and MEDDEV requirements, along with other applicable...
Quality Management System, ISO 149721:2019, Risk Management, Directive (ED)93/42/EEC (MDD) European Union Medical Device...
EU Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) Ability to work effectively...
responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation...
, and the MDD Familiar with Design Control process Excellent written and verbal communication skills Proficiency...
and Medical Device Domain (MDD). 5+years of working experience in managing Critical Manufacturing MES implementations...
, 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...
with FDA regulations, ISO13485, MDSAP, MDD/MDR and other applicable global regulatory requirements for manufacturers...
Clinical Research Associate (with Psychiatry (preferably MDD) experience to join our team! As our next Senior CRA...