Careers that change lives start here. Medtronic is a integral leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.A Day in the LifeWe are a mission-driven leader in medical technology and solutions, with a legacy of integrity and innovation. Work with us to advance better patient care and partner across the industry to make healthcare more affordable and accessible. Become part of a community of experts committed to ensuring high-quality, affordable healthcare worldwide. Come strengthen your specialized skills and grow your experience. We’ll support you with the training, mentorship, guidance, and networks you need to advance, empowering you to work in the way that suits you best. Together, we can take on challenges that will transform the future of healthcare. Join us to build a career that changes lives. This position will be based in Colombia, Bogotá, in a hybrid work model.ResponsibilitiesDirect or perform coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspectionsLead or compile all materials required in submissions, license renewal and annual registrationsRecommend changes for labeling, manufacturing, marketing,



and clinical protocol for regulatory complianceMonitor and improves tracking / control systemsKeep abreast of regulatory procedures and changesMay direct interaction with regulatory agencies on defined mattersRecommend strategies for earliest possible approvals of clinical trials applicationsRequired Knowledge and ExperienceBachelor's degree in Pharmaceutical Chemistry, Biomedical Engineering, Medicine, Chemical Engineering, or related field, and/or practical experience in regulatory processes.0-1 year of relevant experience in regulatory affairs within medical device companiesFluency in English (minimun B2 level required)Experience preparing/validating, renewing, and modifying health registrations.Experience working with regulatory agenciesNice to HaveExperience with medical device regulatory registrationsExperience in internal and external audits and CAPA (Corrective and Preventive Actions)Certifications in Good Practices (GMP, GDP) and ISO 13485Physical Job RequirementsThe 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 & CompensationMedtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to 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).#J-18808-Ljbffr

📌 Assoc Regulatory Affairs Spec (Cundinamarca)
🏢 Medtronic
📍 Cundinamarca