About me

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Rotarian serving the community. Wife and mother of two.

Active, organized, authentic and communicative - in English, Portuguese or Spanish.

Team collaboration, computer savviness and learning something new every day.

  Proactive, organized, communicative and tech savvy.

Spoken and Written fluency in English, Spanish and Brazilian Portuguese.

EDUCATION, LICENSES & CERTIFICATIONS

Dental School of University Santo Amaro, São Paulo — Surgeon Dentist - Dental License – CRO-SP 74240

RAPS Online University – Regulatory Affairs, Medical Devices

Regulatory Affairs Certification, Medical Devices – RAC-Devices

LinkedIn Learning – Project Management

PROFESSIONAL EXPERIENCE 

· Subject matter expert on global medical device and information technology standards, regulations, practices, and government policies. 

· Management and execution of Global Market Access projects with successful Regulatory submissions: FDA 510(k), FCC, CE Mark, NMPA, SFDA, TGA, ANVISA, ANATEL, IFETEL, ENACOM, etc.

· Responsible and accountable for projects’ financial performance: estimates, budget, contracts, ROI analysis and prioritization, execution, and reporting. 

· Author, Reviewer and Approver of Clinical Development Plans, Clinical Evaluation Reports, Periodic Safety Updates Reports and Summary of Safety and Clinical Performance.

· Created and executed regulatory strategies, managing project teams in new products development of and changes to existing products.

· Managed cross-functional and international teams to secure strategic approach to upcoming regulations and market access projects.

· Advisory role to Quality System group to incorporate regulation changes to policies and procedures. 

· Lead role in development and implementation of process improvement. 

EMPLOYMENT HISTORY

Nov 2023 - Present - Undisclosed Medical Device Manufacturer – Senior Regulatory Specialist

Aug 2022 - Nov 2023 - Envista – Principal Regulatory Intelligence Specialist

Jun 2018 – Jul 2022 – A-dec, Inc. – Senior Regulatory Engineer

Oct 2015 – May 2018 - Latin America Regulatory Compliance Group, Bend, OR - Lead Project Manager

Jan 2021 – May 2005 Surgeon dentist in family practice

VOLUNTEERING 

2018 – Present – Member and elected officer (President Elect) of Rotary Club of Newberg Early Birds

2020 – Present – Board Member (Secretary) - Mission Dental Foundation

2022 – Present – Budget Committee Member, Chair - City of Newberg

2023 – Present – Board Member - Newberg Early Birds Rotary Foundation