Highly skilled Consultant Project Engineer with over 14 years of international experience navigating complex regulations in the pharmaceutical and medical device industries. Proven ability to lead decommissioning projects, ensure Quality Management System (QMS) compliance with ISO 9001, 21 CFR Part 210 & 211, and support successful audits from regulatory bodies (FDA, INVIMA, ANMAT, ANVISA, COFEPRIS) and internal teams. Expertise in records management, automation, manufacturing processes, Good Manufacturing Practices (GMP), and validation.Demonstrated success in both project management and regulatory affairs. I led successful decommissioning projects across LATAM in pharmaceutical, API manufacturing, and animal health facilities, ensuring consistent implementation of QMS best practices. As a Regulatory Affairs Specialist, I assessed the impact of the Medical Device Regulation (MDR) on products in 109 countries (ASPAC, EMEAC, LATAM). I developed comprehensive strategies for submissions to health authorities, streamlined inventory management for the Supply Chain, and implemented logistics for external manufacturing across diverse global markets. Additionally, I implemented MDRiM (compliant with ISO 13485) using SharePoint, Tableau, and PowerBI, streamlining regulatory data management for product registrations, submissions, audits, compliance, and HA approvals.Seeking to leverage my project management experience and ongoing education (Renewable Energies and Engineering Management) to transition into the renewable energy industry. Fluent in English (professional), Portuguese (Brazil), and Spanish (native).