- Support Business Unit RA activities including publishing, filing, establishment registrations, product listing with the FDA, etc. - Create and maintain regulatory affairs registrations and licenses in RIMS/GTS distribution control systems in support of regulatory controls for global product distribution. - Release and management of RA blocks. - Generate and communicate GTS/distribution control reports in a timely fashion. - Maintain records (objective evidence) per established procedures. - Maintain GTS/distribution control block tracker. - Perform and support User Acceptance Testing (UAT) as needed for RIMS and GTS. - Work closely with global RA teams and customer service to resolve issues related to GTS/distribution control blocks and maintenance of objective evidence. - Conduct appropriate gap analysis on the existing license master data and develop summaries using advanced Excel and other data analysis tools. - Upload and maintain RA data in RIMS and GTS system using automated upload tools and troubleshoot data errors as needed. - Ability to apply technical expertise in data mining and modeling tools to provide insights into distribution control data for RA and suggest appropriate measures for enhancement of existing processes. - This position requires a level of understanding of software validation and testing protocols. - This position requires an understanding of medical devices regulations and their use. - Understanding of distribution, logistics and order flow from various Enterprise Resource Planning (ERP) Systems used by the company to GTS. - Conduct training for the team members on tools and techniques for maintaining data integrity. - Support the creation of training materials and work instructions. - Support the generation of queries, metrics and reports. - Maintain compliance with RA Procedures and Work Instructions. - Ability to work with cross-functional teams.