REGULATORY AFFAIRS SPECIALISTS

Gather and analyze information for product codes, device description, FDA listing numbers and GMDN codes. Design, develop, test, document & support of cGxP systems asper 21CFR Part11 & US FDA. Responsible for qualification & validation (IQ/OQ/PQ), master plans, protocols, changes requests, gap & root cause analysis, risk management plans, traceability matrix, summary reports for facilities, equipment, systems & processes. Prepare, review, authorize & submission of documentation for quality compliance & regulatory authorities. Skills required: EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD. Bachelor’s degree in Chemistry, Regulatory Affairs, Biology, Health Science or any related field with 5 years of experience in job offered or related occupation is required. Work location: Iselin, NJ and various unanticipated locations throughout the U.S.Send Resume to HR Dept., Intellectt, Inc., 517 Route 1 South, Suite 1115, Iselin, NJ 08830.