Careers that Change Lives
In 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 experience Advance proficiency in both Spanish and English required (reading, writing, and speaking) Minimum 2 year of relevant Regulatory Affairs experience in medical devices or pharmaceutical industry Ability to work in matrix structured organization Document interpretation, queries, and workflow skills Excellent communication and presentation skills Analytical and problem-solving skills; Strategic thinking and decision-making skills Strong organization and time management skills Ability to work as a team Nice to Have Proficiency in Portuguese High understanding of market and laws for medical devices in Latin-American countries About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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