REGULATORY AFFAIRS SPECIALISTS

REGULATORY AFFAIRS SPECIALISTS - Intellectt, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U.S: Gather & anlyz info for prod codes, device descrptn, FDA listing numbs & GMDN codes. Dsgn, dvlp, test, doc & suprt of cGxP sys asper 21CFR Part11 & US FDA. Responsible for qualfctn & valdtn (IQ/OQ/PQ), master plns, protocols, chngs requests, gap & RCA, risk mgmt plans, tracablty matrix, sumary rprts for facilities, equpmnt, sys & proceses. Prep, rvw, authorze & submisn of doc for qlty complince & regultry authorities. Skills req'd: EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD. Master's in Chem, Reg Affiars, Bio, Health Sci or any rltd fld w/1 yr exp in job off'd or rltd occup is req'd. Mail resume: HR, Intellectt, Inc, 517 Rte 1 S, Ste 1115, Iselin, NJ 08830 recblid 7jl76lh21wrwhslj9wf9j8kfb7hec5

Created: 2024-11-05