Senior Regulatory Operations Specialist Senior Regulatory Operations Specialist Apply remote type Remote locations Bogotá, Bogota, Colombia time type Full time posted on Posted 2 Days Ago time left to apply End Date: January 7, 2025 (16 days left to apply) job requisition id R16940 At Medtronic you can begin a life-long 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 The Senior Regulatory Operations Specialist will drive collaboration in interconnected processes; GTS strategy activation and implementation; support/lead transformational projects. This Role is Remote based in Colombia. Responsibilities may include the following and other duties may be assigned: Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents (e-CTD) Support activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs Ensure continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors Prepare, submit, track, index and archive paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials Required Knowledge and Experience: Bachelor's degree Five years of experience in regulatory affairs or related areas. Fluent in English Proficient in Microsoft Office (Outlook, Excel, Word, PowerPoint) Growth, and global mindset Ability to transform knowledge into solutions (automations / digitization) 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 they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package 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 90,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. Who We Are We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. What We Do We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions. How We Are Different These commitments set our team apart from the rest: Experiences that put people first . Respect for people is the hallmark of our humanity. Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. Better outcomes for our world . Here, it's about more than the bottom line. Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. #J-18808-Ljbffr