Jose Pomares
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Sr Regulatory Affairs Supervisor @ Medtronic | RA Strategy | LATAM & SEA | Championing Digital Transformation Initiatives
Bogotá, Bogota, Colombia
Résumé
Jobs
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Sr Regulatory Affairs SupervisorMedtronicSep 2025 - Current (1 year)Business continuity for Neuroscience - LATAM & Southeast Asia Key Achievements: Process Innovation & Automation: Spearheaded the digital transformation of regulatory tracking by designing and deploying an automated tool using Microsoft Power Automate, Lists & SharePoint. This initiative eliminated manual redundancies, improved data integrity, and streamlined approval notification workflows for the region. Strategic Compliance (MDR Transition): Managed the strategic transition plan from MDD to EU MDR standards for several Business Units. Led cross-functional planning to ensure uninterrupted market access and compliance for the portfolio. Quality Leadership: Acting as CAPA Owner for systemic process improvement. Stakeholder Managemen- Sr Regulatory Affairs Specialist SSC - LatAmMedtronicMay 2020 - Sep 2025 (5 years 5 months)New Product Introduction (NPI) Strategy: Managed the regulatory strategy and execution for new registrations across key business lines, including Surgical Robotics, Spine, and Stapling technologies, ensuring timely market access. Complex Manufacturing Transfers: Led large-scale manufacturing site transfer projects impacting thousands of Customer Facing Numbers (CFNs). Coordinated regulatory actions across more than 12 LATAM countries to maintain compliance and supply continuity during transitions.
- Senior Regulatory AdvisorGSKJul 2018 - Apr 2020 (1 year 10 months)Strategic Compliance & Lifecycle Management: Led regulatory strategies for new registrations, renewals, and lifecycle changes across the pharmaceutical and medical device portfolios. Managed regulatory information systems (Liquent, CDMS) and ensured data integrity for all submissions. Audit Readiness & Health Authority Liaison: Acted as a key member of "Rapid Response Teams" to address Health Authority queries efficiently and minimize delays. Lead internal self-inspections and managed all aspects of regulatory audits, ensuring strict compliance in regulatory data.
- Senior Regulatory Affairs AssociatePfizerJul 2017 - Jul 2018 (1 year 1 month)GCMC Regional Strategy: Served as Author and Regional Strategist for the Global Chemistry Manufacturing and Control (GCMC) unit. Coordinated the development of robust dossiers for new registrations and lifecycle maintenance, ensuring alignment with both local regulations and global standards. Stakeholder Management: Streamlined communication between local Health Authorities and internal regulatory partners regarding submissions and approvals. Managed complex requirement responses to ensure timely market access for the portfolio under responsibility.
- Regulatory Affairsgrupo amareyAug 2014 - Jul 2017 (3 years)Dossier Compilation & Submission: Executed end-to-end regulatory submissions, including the preparation of Summary Technical Documents and Device Design Dossiers. Reviewed critical submission documents to ensure high-quality standards before delivery to authorities. Regulatory Support & Intelligence: Provided technical guidance to cross-functional teams on labeling, training, and advertising materials. Monitored emerging regulations to advise on the scope and impact for new business projects.
- OClinical PharmacistOncologíaFeb 2011 - Jul 2014 (3 years 6 months)Clinical Pharmacy Management: Managed pharmaceutical care protocols and quality management systems to ensure patient safety. Ensured compliance with healthcare service licensing and provided drug information to medical teams.
- Regulatory Affairs AnalystPROCAPS LaboratoriesSep 2009 - Jun 2010 (10 months)Regulatory Support: Assisted the regulatory team in the compilation of dossiers for product renewals and maintained databases for ongoing registrations.
Education
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- Postgraduate study, Blockchain technologyIEBS Business SchoolJan 2019 - Jan 2020 (1 year 1 month)
- Postgraduate Diploma In Management, Business Administration and ManagementUniversidad Externado de ColombiaJan 2018 - Jan 2020 (2 years 1 month)
- Estadística Aplicada en R, StatisticsPontificia Universidad JaverianaJan 2016
- Verificador para la Habilitación de Prestadores de Servicios de Salud, Health/Health Care Administration/ManagementUniversidad el BosqueJan 2013
- Bachelor of Pharmacy - BPharm, Pharmacy Administration and Pharmacy Policy and Regulatory AffairsUniversidad de Cartagena ColombiaJan 2004 - Jan 2009 (5 years 1 month)
Projects (professional or personal)
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- AAutomated Regulatory Tracking System (Power Automate)Designed a custom low-code solution to automate the reception, storage, and tracking of regulatory approvals. Reduced manual tracking time and increased visibility for regional stakeholders using Power Automate flows connected to SharePoint Lists.