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 as per 21CFRPart11 & 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 Science, Engineering, Pharmaceutical Science, Pharmacy, Chemistry, Regulatory Affairs, Biology, or Health Science (any) with 5 years of experience in the job offered or related occupation is required. Work location: Minneapolis, MN and various unanticipated locations throughout the U.S. Send Resume to HR Dept., U.S. Electronics, Inc. DBA Lumin Innovations, Inc., 900 Colorado Avenue S., Minneapolis, MN 55416.