At Medtronic, you can begin a lifelong career of exploration and innovation while 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 around the world. The Senior Regulatory Affairs Specialist coordinates and prepares document packages for regulatory submissions. This role is hybrid and based in Bogotá, Colombia. Responsibilities may include the following, and other duties may be assigned: 1. Coordinate and prepare document packages for regulatory submissions from all areas of the company, including internal audits and inspections. 2. Lead or compile all materials required for submissions, license renewals, and annual registrations. 3. Recommend changes for labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance. 4. Monitor and improve tracking and control systems. 5. Stay updated on regulatory procedures and changes. 6. Interact directly with regulatory agencies on defined matters. 7. Recommend strategies for the earliest possible approvals of clinical trial applications. Required Knowledge and Experience: 1. Bachelor’s degree. 2. Four years of experience in regulatory affairs or regulatory operations. 3. Fluent in English. 4. Proficient in Microsoft Office (Outlook, Excel, Word, PowerPoint). 5. Growth mindset and global perspective. 6. Ability to work in a matrix-structured organization. 7. Experience with SAP and GTS is advantageous. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but are not an exhaustive list of all responsibilities and skills required. Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. We are committed to our employees' well-being, recognizing their contributions and sharing in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our mission — to alleviate pain, restore health, and extend life — unites a global team of over 95,000 passionate people. We are engineers at heart—putting ambitious ideas to work to generate real solutions for real people. From R&D; labs to the factory floor and conference rooms, everyone at Medtronic experiments, creates, builds, improves, and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. #J-18808-Ljbffr