Tabitha Barbosa
Winterville,NC
Summary
Results-driven Regulatory Affairs Specialist with a proven track record in global compliance, effective communication, and technical documentation management. Skilled in navigating complex regulatory landscapes and fostering stakeholder relationships.
Overview
5
5
years of professional experience
Work History
Regulatory Affairs Specialist
Candela Corporation
Marlborough, USA
03.2023 - Current
- Collaborated in multidisciplinary teams to convey regulatory requirements effectively.
- Ensured compliance with local and regional registration requirements across LATAM, APAC, and EMEA.
- Evaluated regulatory impacts of proposed design and manufacturing changes.
- Monitored evolving global regulations affecting submissions and practices, communicating updates to stakeholders.
- Fostered strong working relationships with internal and external stakeholders for enhanced collaboration.
Regulatory Affairs Specialist
Actalent Services, Inc. (Client: Arthrex, Inc)
Raleigh, USA
03.2021 - 03.2023
- Coordinated quarterly preparation of applications for Certificates to Foreign Governments.
- Interfaced with regulatory agencies and international consultants throughout Latin America.
- Collected registration data from Engineering, R&D, Manufacturing, and Quality Assurance departments.
- Assembled technical data to create comprehensive device registration dossiers.
- Managed document and registration requests from in-country subsidiaries.
- Identified process improvements to enhance operational efficiency.
- Reviewed labeling accuracy and completeness for medical devices.
Insurance Agent
Anchor Insurance
Greenville, USA
10.2020 - 03.2021
- Sold diverse insurance policies to businesses and individuals, driving revenue growth for insurance companies.
- Analyzed client requirements to develop customized insurance plans that addressed specific needs.
- Coordinated timely responses to inbound inquiries via telephone and email, enhancing customer satisfaction.
- Sourced new clients monthly through strategic networking and targeted outreach initiatives.
Education
Master of Business Administration - International Management
ECU College of Business
Greenville, NC05.2020
Bachelor of Science - Business Administration, Marketing
ECU College of Business
Greenville, NC12.2018
Skills
- Regulatory compliance and submissions
- Technical documentation management
- Global regulations and compliance
- Effective communication and collaboration
- Change control processes
- Attention to detail
- Continuous improvement strategies
- Regulatory research and analysis
- Stakeholder engagement
- Regulatory agency applications
- Medical device regulations
- Labeling and packaging standards
Languages
- Brazilian Portuguese, Fluent
- Spanish, Basic proficiency
Timeline
Regulatory Affairs Specialist
Candela Corporation
03.2023 - Current
Regulatory Affairs Specialist
Actalent Services, Inc. (Client: Arthrex, Inc)
03.2021 - 03.2023
Insurance Agent
Anchor Insurance
10.2020 - 03.2021
Master of Business Administration - International Management
ECU College of Business
Bachelor of Science - Business Administration, Marketing
ECU College of Business
Similar Profiles
Alexander Tacuri AlvearAlexander Tacuri Alvear
Electrical Mechanic at Candela Systems CorporationElectrical Mechanic at Candela Systems Corporation
Gustavo Adolfo Manrique Velazco VelazcoGustavo Adolfo Manrique Velazco Velazco
Co-Owner at Candela Estudio MexicoCo-Owner at Candela Estudio Mexico
Jorge F. Hernández LagoJorge F. Hernández Lago
Bartender at CandelaBartender at Candela
Joshua LeakJoshua Leak
Formulation Technician at Thermo Fisher ScientificFormulation Technician at Thermo Fisher Scientific
Joanna MurphreyJoanna Murphrey
Disability Claims Examiner at Lincoln Financial GroupDisability Claims Examiner at Lincoln Financial Group