Medtronic Bogota, D.C., Capital District, Colombia Join or sign in to find your next job Join to apply for the Regulatory Operations Specialist role at Medtronic Medtronic Bogota, D.C., Capital District, Colombia Join to apply for the Regulatory Operations Specialist role at Medtronic At Medtronic, you can begin a lifelong career of exploration and innovation, helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic is among the largest medical technology companies in the world. Through innovation and collaboration, Medtronic helps to alleviate pain, restore health, and extend life. Last year, our medical therapies for the treatment of over 40 major conditions improved the lives of more than 75 million people worldwide. This position is part of the Global Regulatory Operations Group within the Medtronic Clinical & Regulatory Solutions (MCRS) organization, supporting regulatory systems and processes. Primary responsibilities include providing support for regulatory systems and projects, including distribution control activities for U.S. product release using Global Trade Services (GTS) application in SAP, reporting, tracking activities, and escalating unresolved issues to the regulatory affairs manager. The role primarily interfaces with regulatory affairs teams, regulatory operations teams, managers, and directors. A role in MCRS offers opportunities such as being part of a global team, collaborating across the company, gaining visibility into global structures, and understanding various processes and functions. This role is remote based in Colombia. Responsibilities may include the following: Support U.S. product release activities such as license creation, managing blocked orders, and UDI submissions. Validate and create GTS licenses according to regulatory information and approval documentation. Review and resolve blocked orders, monitor stakeholders, and ensure proper management. Maintain documentation support on SharePoint. Coordinate communication with cross-functional teams including Master Data Management, Supply Chain, Sales, and Customer Service. Provide training to stakeholders and junior team members. Work within systems like FDA systems, SAP/GTS, UDI RA portal, CalyxRIM, InSightDX, Enovia, Agile MAP, and others for managing changes and submissions. Participate in process monitoring, metrics reviews, lean sigma projects, and CAPAs to improve processes. Support audits and verify SOPs and work instructions. Maintain a basic understanding of regulatory requirements and stay updated on changes. Required Knowledge and Experience: Bachelor’s degree Two years of relevant experience in regulatory affairs Fluent in English Proficient in MS Office and Excel Ability to work in a matrix organization Experience with SAP and GTS is required Physical Job Requirements The above statements describe the general nature of the work but are not exhaustive of all responsibilities and skills required. Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. We recognize contributions and support employees at every stage of their careers and lives. The position is eligible for the Medtronic Incentive Plan (MIP). About Medtronic We lead global healthcare technology, attacking the most challenging health problems with innovative solutions. Our mission is to alleviate pain, restore health, and extend life, driven by a team of over 95,000 passionate people. We are engineers at heart—creating solutions from R&D to manufacturing to solutions. Learn more about our business, mission, and diversity efforts. #J-18808-Ljbffr