Marcelo Dourado Email & Phone Number

State Of São Paulo, Brazil

São Paulo, São Paulo, Brasil

Líder para latam nas áreas de Assuntos Regulatórios, Garantia e Sistemas de Gestão da Qualidade. Responsável pela estratégia regional para produtos (time to market). Liderar e suportar regionalmente o Sistema de Gestão da Qualidade, com base na ISO 13485 e regulamentações locais (ANVISA, Cofepris, ANMAT, INVIMA, etc) e outros requisitos regulamentares globais e Auditorias MDSAP.

São Paulo, São Paulo, Brasil

Brazil / Panamá

Reporting to the VP of Quality & Regulatory Affairs in the Netherlands and to the CEO LATAM. Expatriation to Panama from 01/2018 to 12/2020. People management, monitoring the backlog, approvals and conducting strategic actions with the team. Member of Philips LATAM Executive Committee.Company Representative as Advisor at ABIMED and ABIMO(Board Member). Maintenance and implementation of medium and long-term compliance, regulatory and quality policies. Development of actions in multidisciplinary teams to increase the level of awareness and culture of QA & RA (Quality & Regulatory). Management of compliance with FDA regulations, ISO 13485, ISO 9001 and the standards of other regional Regulatory Agencies (Good Manufacturing Practicies). Management of customer complaints handling, post-market surveillance, nonconformity and CAPA (Corrective Action and Preventive Action). Management of manufacturing inspections and audits, products, records, product recall activities, LATAM Audit program and processes. Monitoring of results, analysis of KPIs and compliance with costs in the area. Restructuring of the Regulatory area, including Regulatory Intelligence. Relationship with regulatory bodies and trade associations in Latam level (regional). To identify risks for complex regulatory strategies and analyze local regulatory trends and market intelligence. To develop RA relationship with Distributor RA counterparts and supports Distributor RA activities. Cost reduction projects, deadlines, risks and impacts and insertion of the policy for NPI (New Product Introduction) in the market and MDSAP Audit. Support the organization on creating a culture of continuous improvement / LEAN.Environmental management of contaminated soils (Soil Remediation) and decontamination of sites in accordance with Environmental Policies and reverse logistic process. Reorganization of the EHS area and implementation of E-social in the company.

Panamá

Brasil

São Paulo / Brazil

Report to Brazil CEO. Responsible for Regulatory Affairs and Quality Management System, Pos Market Surveillance - Aftermarket, Risk Management, Quality Assurance and Waste Management areas. Management of multidisciplinary teams and support to the team in the development of projects. Establish and implement the overall vision, objectives and strategy for Brazil Regulatory initiatives.Lead the ISO 9001 Quality System Cetification in Brazil.Leader in improvement projects, increase in the profitability and use of tax benefits (ICMS). Complaints management and implementation of Divisional Standards and Policies, as well as the Business Continuity Plan. Execution of strategic planning, budget, and investments for new projects. Manage Latam QA RA team, ensuring clarity around priorities and goals, planning the required resources to meet objectives. Constant analysis of KPIs.Ensures the Good Manufacturing Practices mandated by country regulator (ANVISAl) are appropriately documented through QMS.Manage internal audits in accordance with documented requirements and timelines.

São Paulo, Brazil

São Paulo, Brazil

Project management and all relevant actions in the Regulatory area and product registration with ANVISA. Strong leadership role in project execution and in the development of high-performance teams. Monitoring of costs, budget management, elaboration of the strategic plan, analyzes aimed at improving profitability and sustainability for the business. Participation as Advisor of ABIMED (Board Member). Leader in process improvement projects and related to tax incentives.

Bachelor Of Engineering (B.Eng.), Engenharia Elétrica E Eletrônica

Conselheiro Administrativo

Pós-Graduação Lato Sensu - Mba Executivo, Business/Commerce, General

Pos Graduação, Qualidade E Produtividade