Experience

Grupo Soluto

• Brazil
• Business Consulting and Services
• 1 - 100 Employee

• Senior Regulatory Affairs Analyst

  • Jul 2023 - Present

• Regulatory Affairs Assistant III

  • Feb 2022 - Jun 2023

  - Responsible for supporting clients with healthcare devices registration (initial registration and amendments to the initial registration) meeting ANVISA's requirements based on core legislations such as (but not limited to): RDC 751/2022; RDC 40/2015 and its amendments; RDC 546/2021; RDC 556/2021.- Responsible mostly for supporting clients with the registration of non-active medical devices classified as risk class IIb and risk class III per MDR (EU) 2017/745 (such as stents, heart valves, catheters, etc.); and active implantable medical devices such as pacemakers.- Support and preparation of response letters to the ANVISA's defficiency letters.- Elementary analysis of dossier documentation such as Clinical Evaluation Report; Stability studies; etc.- Good knowledge of ANVISA's required documentation regarding medical devices containing animal tissues or its derivatives.- Knowledge of Resolutions, Laws, Directives, Ordinances and Normative Filling required to register healthcare devices in Brazil (ANVISA).- Core knowledge of Medical Devices Regulation (EU) 2017/745 requirements for healthcare products registration.- Core knowledge FDA requirements for healthcare products registration.- Responsible for updating projects follow-up spreadsheets.- Responsible for co-managing minor projects deadlines with clients according to their marketing strategies.- Responsible for supporting new employees. Show less

• Regulatory Affairs Assistant I

  • Feb 2021 - Feb 2022

  - Responsible for supporting clients with healthcare devices registration (initial registration and amendments to the initial registration) meeting ANVISA's requirements: Filling out ANVISA's form and preparing the technical dossier for medical devices classified as risk class I and risk class II per Resolution RDC 185/2001, and classified as risk class I and risk class IIa per Directive 93/42/EEC. Preparation of dossier documentation for active healthcare devices classified as risk class III and class IV (as per RDC 185/2001; and classified as class IIb and class III per Directive 93/42/EEC). Supervised preparation of dossier documentation for non-active healthcare devices classified as risk class III and class IV (as per RDC 185/2001; and classified as class IIb and class III as per Directive 93/42/EEC). Support and preparation of response letters to defficiency letters (supervisied in case of high risk non-active medical devices).- Good knowledge of Resolutions, Laws, Directives, Ordinances and Normative Filling required to register medical devices in Brazil (ANVISA).- Core knowledge of MDD 93/42/EEC requirements for healthcare products registration.- Scarse knowledge FDA requirements for healthcare products registration.- Responsible for updating projects follow-up spreadsheets. Show less

• Assistant I to the Regulatory Affairs Assistant

  • Jul 2019 - Feb 2021

  - Supporting the Regulatory Affair Assistant with healthcare devices registration (initial and amendments to the initial registration) meeting ANVISA's requirements: Filling out ANVISA's form and preparing the technical dossier for medical devices classified as risk class I and risk class II (as classified per Resolution RDC 185/2001, and classified as risk class I and risk class IIa per Directive 93/42/EEC). Supervised preparation of dossier documentation for active and non-active healthcare devices classified as risk class III and class IV as per RDC 185/2001; and classified as class IIb and class III per Directive 93/42/EEC.- Core knowledge of Resolutions, Laws, Directives, Ordinances and Normative Filling required to register medical devices in Brazil (ANVISA).- Scarse knowledge of MDD 93/42/EEC and FDA requirements for healthcare products registration. Show less



Stoller do Brasil Ltda.

• Brazil
• Farming
• 700 & Above Employee

• Student Internship

  • Mar 2018 - Dec 2018

  - Evaluation of physical compatibility of pesticides in aqueous tank mixtures by the dynamic shaker method (according to guidelines of ASTM E1518-05); - Support in germination and emergence testing of soybean and corn seeds; -Plant morphology evaluation using WinRHIZO® and WinFOLIA®; - Implementation and maintenance of inventory lists using Microsoft Excel; - Laboratory organization; - Knowledge of GLP and PPE. - Evaluation of physical compatibility of pesticides in aqueous tank mixtures by the dynamic shaker method (according to guidelines of ASTM E1518-05); - Support in germination and emergence testing of soybean and corn seeds; -Plant morphology evaluation using WinRHIZO® and WinFOLIA®; - Implementation and maintenance of inventory lists using Microsoft Excel; - Laboratory organization; - Knowledge of GLP and PPE.



BASF

• Germany
• Chemical Manufacturing
• 700 & Above Employee

• Student Internship

  • Jan 2017 - Dec 2017

  - Preparation of fungal culture media for necrotrophic and biotrophic phytopathogenic fungi; - Sterilization of laboratory glassware; - Isolation of phytopathogenic fungi; - Preservation of fungal isolates; - Preservation and maintenance of fungal cultures; - Running antifungal susceptibility testing of phytopathogenic fungi; - DNA extraction from fungi; - Responsible for maintaining an inventory list and organizing the laboratory; - Knowledge of GLP and PPE. - Preparation of fungal culture media for necrotrophic and biotrophic phytopathogenic fungi; - Sterilization of laboratory glassware; - Isolation of phytopathogenic fungi; - Preservation of fungal isolates; - Preservation and maintenance of fungal cultures; - Running antifungal susceptibility testing of phytopathogenic fungi; - DNA extraction from fungi; - Responsible for maintaining an inventory list and organizing the laboratory; - Knowledge of GLP and PPE.