Experience

CTK Biotech, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Jan 2022 - Present

  - I collaborate with Marketing and Sales departments to ensure correct registrations are achieved for in vitro diagnostic test devices in various countries world-wide; - I prepare and submit product dossiers for international registration as well as maintain current registrations; - Ensure compliance with regulatory requirements of all labeling through DCR and ECR approval; - Manage legalization of documents and liaison with appropriate external document legalization agencies such service provider, consulates and embassies; - Assist in the regulatory approval process of product. - Assist in post-approval activities - Gather medical device data from databases - Participate in other regulatory and compliance activities as required, working closely with project teams and other regulatory personnel - IVDR transition and UDI compliance activities Show less



Tribunal Regional do Trabalho da 2ª Região

• Brazil
• Administration of Justice
• 700 & Above Employee

• Administrative Analyst - Process and Project Management Department

  • 2018 - 2020

  I oversaw and led strategic project completion by creating competencies and methodologies to streamline the process and create standardization in practices. My role was to support project managers and teams, continuously setting milestones to propel projects forward and ensure all components were adequately implemented, and providing regular status updates for transparency and validation in completing tasks. I presented and disseminated process-related knowledge and best practices to drive process improvements throughout the organization. Show less



TJDFT

• Brazil
• Administration of Justice
• 700 & Above Employee

• Administrative Analyst

  • 2015 - 2018

  I distributed legal filings to appropriate court departments and ensured transparency in available materials, creating an environment focused on cross-functional collaboration in achieving business objectives. I distributed legal filings to appropriate court departments and ensured transparency in available materials, creating an environment focused on cross-functional collaboration in achieving business objectives.



Self-Study

• Salvador e Região, Brasil

• Self-Study

  • 2011 - 2015

  During this time period, I extensively studied to understand civil, criminal, constitutional, employment, public finance, and administrative laws to pass established tests verifying competence and knowledge to work within public service offices, yielding passing results and future work in the legal departments of the public sector. During this time period, I extensively studied to understand civil, criminal, constitutional, employment, public finance, and administrative laws to pass established tests verifying competence and knowledge to work within public service offices, yielding passing results and future work in the legal departments of the public sector.



Clínica de Terapia Articular

• Salvador, Bahia, Brazil

• Physical Therapist

  • 2010 - 2012

  As a trained Physical Therapist, I provided examination, diagnosis, physical intervention, and rehabilitation for patients with musculoskeletal disorders and other orthopedic needs. As a trained Physical Therapist, I provided examination, diagnosis, physical intervention, and rehabilitation for patients with musculoskeletal disorders and other orthopedic needs.