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Work Background
HoneywellSenior Advanced Regulatory Engineer
May. 2022 - May. 2025Mexico City, Mexico• Experience with registration and post-registration and GMP of Medical Device & Drugs in FDA, Health Canada and EMA. • Established robust tracking systems for regulatory data, improving cross-functional collaboration and risk management. • Work strategically with cross functional team to mitigate risks and avoid delays, as well a regulatory liaison in importation process to avoid products disruption. • Provided regulatory guidance for new product development, enhancing the efficiency of stability studies. • Defined high-level regulatory requirements for multiple countries, facilitating smoother international market entry.
Johnson & JohnsonRegulatory Affairs Specialist
Dec. 2018 - Oct. 2021São Paulo e Região, BrasilDevelopment of 150+ submission dossiers for changes in instruction of use, shelf life, legal and physical manufacturing. Analysis of technical documentation, clinical evaluation, risk analysis, stability tests, GMP and critical analysis in order to comply to Anvisa´s (initials in Portuguese for National Sanitary Surveillance Agency) requirements and to achieve the milestones set in the J&J Global Plan. Post approval activities: official announcements throughout the LATAM team and MDRIM system updates. Execution of the Data Validation Global project, leading the Brazilian branch and achieving 1300+ proceses analysis.
StrykerRegulatory Affairs Analyst
Apr. 2017 - Dec. 2018São Paulo e Região, BrasilDevelopment of 20+ submission dossiers for new product registrations in Brazil and internationally - Anvisa, Inmetro (initials in Portuguese for National Metrology, Quality and Technology Institute), FDA, CE MARK - according to ISO 10993, ISO 14971 and ISO 13485; focused in neurosurgical and orthopedic products/materials. Development of 50+ submission dossiers for legal manufacture changes.
Solótica Vision CareQuality Assurance Analyst and Regulatory Affairs Analyst
Mar. 2015 - Mar. 2017São Paulo e Região, BrasilResponsible pharmacist for the distribution warehouse and transportation according to Anvisa`s requirements. Update and control of documentation for regularization of the company licenses and certifications for 40+ products. Communication with international quality assurance team (Asia, Europe, LATAM and USA) to update documents and processes with the Consulates referent to our imported products. Elaboration of technical file for CE mark and FDA certifications. Factory equipment`s periodic review and validation together with the Engineering team. Brainstorming and decision making of new products together with marketing team. Responsible to receive, process and respond to audit processes with the collaboration of the production team. Development of 15+ submission dossiers for new product registrations in Brazil.
Medi House Ind E Com De Prod Cirurgicos E HospQuality Assurance Analyst
Oct. 2014 - Feb. 2015São Paulo e Região, BrasilPreparation, revision of POPs, legislation and training; Customer complaint: Analysis and investigation of complaints, aiming to improve product quality and production process, elaboration of response letters; Non-Compliance: Elaboration of reports of nonconformities related to internal productive work, quality control and suppliers, evaluation and investigation, corrective and preventive action; Assistance and monitoring of internal audits and inspection of Anvisa and ISO; alibration and Maintenance: Periodic control of the validity of the equipment to be calibrated and its maintenance;
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