What are the responsibilities and job description for the REGULATORY AFFAIRS SPECIALISTS position at VYSoft Solutions Inc?
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 21CFR Part11 & FDA regulations. Plan and perform quality control (QC) and submit regulatory submissions to authorities. Create master and risk management plans, changes requests, traceability matrix, and summary reports. Plan, develop, and manage submissions for programs including INDs, NDAs, and BLAs. Master’s degree in Science, Technology or Engineering (Any); or Regulatory Affairs is required. Work location: Edison, NJ and various unanticipated locations throughout the U.S.Send Resume to HR Dept., VYSoft Solutions, Inc., 40 Brunswick Ave., Suite 205, Edison, NJ 08817.