Job Location : Iselin,NJ, USA
IT POSITIONS - Intellectt, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U.S: REGULATORY AFFAIRS SPECIALISTS 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. Bachelor's in Chem, Reg Affiars, Bio, Health Sci or any rltd fld w/5 yrs exp in job off'd or rltd occup is req'd. Quality Engineers: Perf comprhnsiv failure anlys on device returns, idntfy root causes & reasons for return to enhnc prod reliabiity. Collaborate w/pre market qlty, regltry affairs, research & dvlpmnt & engg team to suprt risk assessment by rvwing FMEA risk docs. Cndct thru anlys of current prod dsgns, impl necessary modifictns to meet specified dimensions. Provide suport for CAPA. Utilize Catia V5 for tool dsgning, ensuring precision & efficiency in dvlpmnt process. Idntify root causes for failures obsrvd in relibility testng, dsgn valdtn, & prod valdtn. Master's in Sci, Tech, Or Engg (any) is req'd. FOR BOTH JOBS: Mail resume: HR, Intellectt, Inc, 517 Rte 1 S, Ste 1115, Iselin, NJ 08830. recblid h6f72wd8of3r75jrtovsnhqy4641sg