Careers that Change LivesIn this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned per Senior Supervisor or RA Manager. While being the focal point for Operating Units (OU) and countries under your scope about regulatory processes for all stakeholders. You will also lead the strategic requirements for local Ministry of Health (MoH) and provide guidance to centre-led team to help plan timelines and registration strategies including initial submission, amendments, changes, and any other regulatory activity for Latin America (LATAM), according to RA Manager and/or Senior RA Specialist instruction. A Day in the Life Responsibilities may include the following and other duties may be assigned: Review submission dossiers, renewals, and respond to Government queries.Follow up with Business, Marketing, cross-functions, and Centre-led team Units to ensure submission planning.Collaborate with centre-led regulatory team on new product and changes that require submission and prior approval. Notify business partners, international, regional, and local teams of approvals.Verify and validate the information to be published in the databases. Train the regulatory team on LATAM regulations and related workflow, and attend any training related to local regulations provided by the RA local teams, consultants, etc.Provide the necessary information to create statistical reports and support budget preparation for LATAM countries.Keep up with changes in regulatory legislation and guidelines as an expert in the regulation.Maintain updated the Medtronic tool (Excel, Smartsheet) designated to track the progress of the regulatory processes.Participate in frequently strategic reviews with Internationals OUs, Business Partners, and RA Local Teams. Must Have: Minimum Requirements BA/BS degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experienceAdvance proficiency in both Spanish and English required (reading, writing, and speaking)Minimum 2 year of relevant Regulatory Affairs experience in medical devices or pharmaceutical industryAbility to work in matrix structured organizationDocument interpretation, queries, and workflow skillsExcellent communication and presentation skillsAnalytical and problem-solving skills; Strategic thinking and decision-making skillsStrong organization and time management skillsAbility to work as a team Nice to Have Proficiency in PortugueseHigh understanding of market and laws for medical devices in Latin-American countries
