Marielen Ribeiro Email & Phone Number

State Of Paraná, Brazil

Curitiba, Paraná, Brasil

- Regulatory actions planning - Standard operating procedures implementation

I managed regulatory certifications and quality, acting as the focal point for the international manufacturer's operational teams.Main results:- Implementation of the Quality Management System- Acquisition and maintenance of Inmetro and Anatel certificates of medical device- Product notification to ANVISA

Curitiba, Paraná, Brasil

I led the implementation of new technology in telehealth projects, driving client engagement and project monitoring.Main results:- Implementation of a proactive approach in monitoring project implementations and managing technical support- Contribution to improve product development

Curitiba, Paraná, Brasil

Implementation and coordination of a clinical research protocol, including planning, training, recruitment, monitoring, and scientific writing. Evaluation of budget proposals for clinical trials protocols.Main results:- Recruitment of 600 pediatric participants- Coordination to prepare the Point of Care (IT requirements and physical infrastructure)- Training of medical staff- Preparation and submission of regulatory documents- Documentation of clinical trial… Show more Implementation and coordination of a clinical research protocol, including planning, training, recruitment, monitoring, and scientific writing. Evaluation of budget proposals for clinical trials protocols.Main results:- Recruitment of 600 pediatric participants- Coordination to prepare the Point of Care (IT requirements and physical infrastructure)- Training of medical staff- Preparation and submission of regulatory documents- Documentation of clinical trial data- Collaboration and communication with departments Show less

Curitiba, Paraná, Brazil

Multidisciplinary residency program held at Hospital Pequeno Príncipe and Municipal Health Department of São José dos Pinhais, which provided experience in clinical analysis, risk management (technovigilance, pharmacovigilance, hemovigilance and biosurveillance), clinical research, epidemiology, control of healthcare-associated infections, epidemiological surveillance and biobanking.Main results:- Implementation of risk management indicators in a hospital- Assessment of… Show more Multidisciplinary residency program held at Hospital Pequeno Príncipe and Municipal Health Department of São José dos Pinhais, which provided experience in clinical analysis, risk management (technovigilance, pharmacovigilance, hemovigilance and biosurveillance), clinical research, epidemiology, control of healthcare-associated infections, epidemiological surveillance and biobanking.Main results:- Implementation of risk management indicators in a hospital- Assessment of transfusion requests and proposal of a reviewed transfusion protocol in a hospital Show less

Regulatory Affaris, Good Practices And Audit For Medical Devices, Rdc 665/22 Anvisa

Master'S Degree, Biotechnology Applied To Pediatrics

Specialization, Project Management

Activities and Societies: "Desenvolvimento de abordagem preditiva para implementação de projetos com dispositivo médico no setor de saúde."

Specialization, Residency Program In Pediatrics

Bachelor'S Degree, Biomedical Science, Clinical Analyses And Research

Activities and Societies: Habilitação em Análises Clínicas