- Avaliação das necessidades dos clientes e formulação de soluções, inovando, refinando e aprimorando constantemente esses serviços ao longo do ciclo de vida da consultoria.- Apoio no desenvolvimento de instruções de uso, embalagem e rotulagem de produtos de acordo com os requisitos da ANVISA.- Revisão e avaliação das atividades de controle de alterações para um impacto potencial nos atuais registros regulatórios.- Apoio técnico para as publicações da empresa em suas mídias.-… Show more - Avaliação das necessidades dos clientes e formulação de soluções, inovando, refinando e aprimorando constantemente esses serviços ao longo do ciclo de vida da consultoria.- Apoio no desenvolvimento de instruções de uso, embalagem e rotulagem de produtos de acordo com os requisitos da ANVISA.- Revisão e avaliação das atividades de controle de alterações para um impacto potencial nos atuais registros regulatórios.- Apoio técnico para as publicações da empresa em suas mídias.- Consultoria sobre submissão e obtenção da Certificação de Boas Práticas de Fabricação de empresas internacionais de acordo com a RDC 665/2022.- Identificação e implementação de estratégias regulatórias.- Preparo e envio de submissões regulatórias de acordo com a RDC 751/2022 e RDC 36/2015 (RDC 830/2023).- Vivência na regulamentação e procedimentos e certificação ANVISA, INMETRO e ANATEL.- Relacionamento com as autoridades regulatórias e clientes antes e durante o desenvolvimento e revisão de uma submissão regulatória por meio de ferramentas de comunicação apropriadas. Show less

As RT and responsible for the Regulatory Affairs and Quality areas, I am responsible for managing tools and processes in order to deliver the best result to the company and its customers. This includes: - Managing the lifecycle of the company's registration processes with ANVISA, presenting 100% approval in the submitted processes, classes I, II, III and IV. - Maintain direct communication with customers, suppliers and ANVISA about regulatory issues. - Keep all licenses and… Show more As RT and responsible for the Regulatory Affairs and Quality areas, I am responsible for managing tools and processes in order to deliver the best result to the company and its customers. This includes: - Managing the lifecycle of the company's registration processes with ANVISA, presenting 100% approval in the submitted processes, classes I, II, III and IV. - Maintain direct communication with customers, suppliers and ANVISA about regulatory issues. - Keep all licenses and certifications necessary for the company's active operation. - Keep the certifications applicable to active suppliers. - Manage the Quality Management System and its documentation, including customer complaints, preventive and corrective actions, KPI management and actions for countinuous improvement. - Provide regulatory support to Senior Management and other sectors of the company. Show less

Responsible for registering products (new, revalidations, changes and requirements), with 100% of deferred processes under my responsibilityImplementation of the company's Quality Management System, including manuals, procedures and other documents.Implementation of the Certification of Good Storage and Distribution PracticesSupervision of the product entry inspection process.Responsible for the company's contact with health regulatory bodies.Responsible for the Customer… Show more Responsible for registering products (new, revalidations, changes and requirements), with 100% of deferred processes under my responsibilityImplementation of the company's Quality Management System, including manuals, procedures and other documents.Implementation of the Certification of Good Storage and Distribution PracticesSupervision of the product entry inspection process.Responsible for the company's contact with health regulatory bodies.Responsible for the Customer Complaint and Non-Conformities ResolutionLicense maintenance Show less

Implementation of the University's Ombudsman System (process design, technical documentation and operationalization).Maintenance of indicators related to customer satisfaction.Contact with the directors of the units across the country in search of continuous improvement and monitoring the satisfaction of the end customer.Communication with customers about their demands.

Responsible for the customer feedback process, aiming to reach the maximum level of satisfaction of internal and external customers with the service provided by the School. Mapping of internal processes. Using the Visio tool. Preparation of QMS documents Participation in internal QMS audits Participation in internal marketing projects and internal training.

Monitoring the preparation of technical product dossiers in the processes for registering new products, changes and revalidations of product current registration and following up with analysts the contacts with representatives and / or international regulatory agencies. Critical analysis of national and international standards and legislation related to authorization for manufacturing and registering products. Implementation of the Quality Management System in the activities of the… Show more Monitoring the preparation of technical product dossiers in the processes for registering new products, changes and revalidations of product current registration and following up with analysts the contacts with representatives and / or international regulatory agencies. Critical analysis of national and international standards and legislation related to authorization for manufacturing and registering products. Implementation of the Quality Management System in the activities of the Department and related processes, including the maintenance of the applicable quality records. Participation as an Auditor in Internal Audits Contact with the company's marketing area, to define registration priorities regarding the organization's commercial interests; Continuous contact with company representatives in the countries where it sells its products, to support the registration and intermediation processes in the company / representative / ministry of health relationship. Coordination of the registration processes performed by the team, with schedule monitoring, and elaboration of monitoring reports. Support in the elaboration of registration dossiers Elaboration of strategies to improve internal methodologies and identification of improvement opportunities. Show less

Preparation of product registration dossiers (new registrations, changes and revalidations), based on the documentation available in the QMS, focusing on countries in Latin America and Brazil, with success in 100% of the processes under responsibility. Contact with customers in your focus area, to follow-up the registration processes. Interpretation of laws and regulations. Post-registration follow-up

Preparation of QMS documents. Monitoring of non-conformities, preventive and corrective actions, keeping the information updated and available.

Participation in new product development projects; Preparation of Risk Management Reports and Bibliographic Reviews on the use of medical devices, reported in the scientific literature.

Estagiária no Laboratório de Estruturas de Superfície de Vírus Envelopados e Interferons, Departamento de Virologia.Publicação de trabalho em congresso da Sociedade Brasileira de Virologia: "Detection of Antibodies for Influenza A (H3N8) Virus Neuraminidase in Human Sera".

Estágio de graduação no Instituto de Pesquisas Gonzaga da Gama Filho, na área de Análises Clínicas, nas áreas de Hematologia, Microbiologia, Imunologia, Virologia e Parasitologia.