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 Regulatory Affairs Specialist supports the execution of regulatory strategies across Latin America by managing submissions, coordinating documentation, and ensuring compliance with evolving regulations. This role is ideal for someone with solid experience in regulatory affairs, strong cross\-functional collaboration skills, and a strategic mindset. As part of a global team, the RAS will work closely with internal stakeholders, business partners, and operating units to drive regulatory efficiency and ensure timely submissions. The position requires advanced communication skills and the ability to manage complex workflows across geographies. This is a remote role with occasional in\-person collaboration, and candidates must reside in Colombia. **Responsibilities may include the following and other duties may be assigned:** * Create and follow up on insight applications, events, and tasks * Clarify regulatory questions from Business Units (BU) * Complete local registration applications and design monographs for Brazilian submissions * Draft technical reports and monographs that support registration history * Manage and distribute legal documents (CFGs, FSCs, ISOs) * Oversee translation management for assigned clusters * Build and validate dossiers for all LATAM countries, including double\-checks for Mexican submissions * Coordinate submission planning with Business Partners and Operating Units * Respond to government inquiries and support RAN management under RA Manager guidance * Notify stakeholders of approvals across sOU , international, regional, and local teams * Verify and validate data for publication in regulatory databases * Collaborate with Sr. RAS, Associate RAS, and Project Coordinators * Train regulatory teams on LATAM regulations and workflows * Attend internal and external regulatory training sessions * Provide data for statistical reports and support budget tasks for LATAM countries * Assist Regulatory Operations with RAC assessments, blocked orders, and batch releases * Support audits, importations, tenders, and inventory deployment as needed * Stay current on regulatory legislation and guidelines * Maximize team efficiency by executing strategies that impact the broader RA function (e.g., master dossiers) * Maintain tracking tools (Excel, Smartsheet) for regulatory process advancement * Provide backup support to fellow RAS team members * Actively participate in strategic reviews and SSC projects with international teams **Require** **d** **Knowledge and Experience** **:** * Bachelor’s degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or related field * Minimum 2 years of experience in regulatory affairs * Advanced proficiency in Spanish and English (reading, writing, speaking) * Fluent in English; Portuguese proficiency preferred * Experience in medical devices or pharmaceutical industry * Strong understanding of LATAM regulatory environments and market dynamics * Ability to work in a matrix\-structured organization * High proficiency in Microsoft Office tools and database management * Excellent communication and presentation skills * Strong analytical, problem\-solving, and decision\-making abilities * Ability to manage multiple projects and meet deadlines * Team\-oriented with a proactive and strategic mindset **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** 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). **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 95,000\+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R\&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.