responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation...
and Medical Device Domain (MDD). 5+years of working experience in managing Critical Manufacturing MES implementations...
, and the MDD Familiar with Design Control process Excellent written and verbal communication skills Proficiency...
with FDA regulations, ISO13485, MDSAP, MDD/MDR and other applicable global regulatory requirements for manufacturers...
and ability to implement corporate and divisional strategy Knowledge of FDA/GMP/MDD, ISO 13485, CFDA regulations...
spanning 6 locations and 40+ providers. PNSCR conducts phase II-IV psychiatry trials for indications including MDD...
for ensuring that production processes and employees comply with regulatory standards (FDA, cGMP, ISO13485, MDD and Country-Region...
Clinical Research Associate (with Psychiatry (preferably MDD) experience to join our team! As our next Senior CRA...
of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR. Experience...
9001, and the MDD. Familiar with Design Control procedures and requirements. Demonstrated excellent written and verbal...