Medtronic Bogota, D.C., Capital District, Colombia Join or sign in to find your next job Join to apply for the Senior Regulatory Affairs Specialist role at Medtronic Medtronic Bogota, D.C., Capital District, Colombia 4 days ago Be among the first 25 applicants Join to apply for the Senior Regulatory Affairs Specialist role at Medtronic 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 worldwide. The Senior Regulatory Affairs Specialist coordinates and prepares document packages for regulatory submissions. This role is hybrid-based in Bogotá, Colombia. Responsibilities may include the following, and other duties may be assigned: Coordinate and prepare document packages for regulatory submissions from all areas of the company, internal audits, and inspections. Lead or compile all materials required in submissions, license renewals, and annual registrations. Recommend changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance. Monitor and improve tracking/control systems. Keep abreast of regulatory procedures and changes. Interact directly with regulatory agencies on defined matters. Recommend strategies for the earliest possible approvals of clinical trial applications. Required Knowledge and Experience: Bachelor’s degree Four years of experience in regulatory affairs or regulatory operations Fluent in English Proficient in Microsoft Office (Outlook, Excel, Word, PowerPoint) Growth and global mindset Ability to work in a matrix-structured organization Experience with SAP and GTS is advantageous Physical Job Requirements The above statements describe the general nature and level of work performed by employees in 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 recognize our employees' contributions and support them at every career and life stage with a range of benefits, resources, and competitive compensation plans. 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 seeking 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—transforming ambitious ideas into real solutions for real people. From R&D to manufacturing to corporate, we innovate continuously, bringing diverse perspectives and courage to engineer the extraordinary. Additional Information Seniority level: Mid-Senior level Employment type: Full-time Job function: Legal Industries: Medical Equipment Manufacturing, Hospitals and Healthcare, Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Medtronic by 2x. Set job alerts for “Senior Regulatory Affairs Specialist” roles. #J-18808-Ljbffr