Looking for a job

Caroline Machado

@carolinemachado

Regulatory Affairs and International Trade professional driving compliant product approvals and efficient global supply.

Brazil

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What I'm looking for

I’m looking for a new position as a Regulatory Affairs Specialist or International Trade Specialist in my areas of expertise, with openness to new opportunities in other areas.

I’m a Regulatory Affairs Specialist with solid expertise in import and export management, regulatory compliance, and direct liaison with authorities including ANVISA, FDA, TUV SUD, and BSI. At Medtronic Brazil, I analyze regulations and standards, prepare regulatory dossiers, and support product registration and post-registration processes with tight critical-deadline control.

I strengthen regulatory readiness through structured documentation and governance—migrating technical documentation to the GSSD template, aligning Essential Requirements to EPC using IMDRF guidance, and creating/maintaining GTS License to avoid Regulatory blocks in the US territory. I also coordinate cross-functional alignment across R&D, Labeling, Manufacturing, Quality, Design, Marketing, and Clinical, and lead front-room audit involvement by presenting regulatory evidence and ensuring compliance.

Earlier, as a Demand and International Trade Analyst and Supply Chain Analyst, I built operational muscle in global demand, inventory control, and import/export workflows—working with brokers, freight forwarders, suppliers, and management on forecasts, backorder mitigation, and shipment schedules. I’ve also improved systems and efficiency by creating ERP modules for sanitary licenses, implementing Protheus export/import modules, and supporting IT interfaces between SAP and Protheus, using tools such as Power BI and CAP/MAP Agile for continuous improvement.

Experience

Work history, roles, and key accomplishments

Regulatory Affairs Specialist

Medtronic - Brazil

Feb 2024 - Feb 2026 (2 years)

Ensured regulatory compliance for medical devices by analyzing applicable standards and preparing regulatory dossiers for ANVISA, TUV SUD, and BSI, including ISO 13485, ISO 14971, ISO 10993, ISO 14155, and ISO 15223 requirements. Led technical documentation migrations (GSSD, ER to EPC), maintained US GTS licensing, supported design/manufacturing/sterilization change regulatory assessments, and coo

Regulatory Affairs ANVISA ISO 13485 ISO 14971 ISO 14155 IMDRF ER To EPC CAPA And SOP Change Impact FDA US GTS Licensing

Regulatory Affairs Specialist

Medtronic

Feb 2024 - Feb 2026 (2 years)

Led regulatory submissions for 2,000+ medical device SKUs across ANVISA and LATAM, reducing approval time by 45% through GSSD standardization. Managed authority/audit responses and resolved U.S. regulatory holds to achieve zero rejections (2023–2025) and improve import efficiency by 15%.

Regulatory Submissions ANVISA & LATAM GSSD Documentation ISO 13485 ISO 14971 CAPA & Non Conformities (NC)Audit Readiness

International Trade Analyst

Medtronic - Brazil

Jan 2019 - Feb 2024 (5 years 1 month)

Managed import and export processes for Brazilian manufacturing sites, coordinating with brokers, freight forwarders, and international suppliers. Controlled inventory delivery/shipment dates, supported backorder mitigation with Sales and Marketing, maintained SAP master data for new SKUs, and handled supply chain planning, costing, international purchasing, and export/import technical assistance.

Import Export Processes Inventory Control Freight forwarding Demand Forecasting Supply Chain Planning

Demand Planning & Trade Analyst

Medtronic

Jan 2019 - Feb 2024 (5 years 1 month)

Managed import/export operations across 15+ countries and two manufacturing sites, coordinating with customs brokers, freight forwarders, and global suppliers to optimize logistics costs and timelines. Automated shipping documentation, reducing processing time from 1 hour to 5 minutes.

International Trade Operations Freight forwarding Regulatory Sanitary License Compliance Cross Functional Collaboration

Supply Chain Analyst

Avа Ind. E Com. Móveis

Jan 2015 - Dec 2018 (3 years 11 months)

Supported inventory data analysis and stock control optimization by monitoring order flow to meet delivery deadlines. Coordinated with suppliers to negotiate favorable conditions, verified incoming product conformity to quality standards, organized supply chain documents, and supported day-to-day operational tasks to improve speed and efficiency.

Inventory Analysis Stock Control Order Flow Monitoring Document Control Supply Chain Operations Data Management

Supply Chain Analyst

AVA Ind. E Com. Móveis

Jan 2015 - Jan 2018 (3 years)

Analyzed inventory and implemented stock optimization strategies to improve inventory control. Monitored order fulfillment to support on-time delivery and managed supply chain documentation and reporting processes.

Inventory Control Reporting Data Analysis On Time Delivery Process Improvement

Education

Degrees, certifications, and relevant coursework

HSC Global

Medical Device Register at FDA Certification, FDA Medical Device Registration

2026 -

International certification focused on Medical Device Register at the FDA; currently studying (started 2026).

HSC Global

FDA Medical Device Registration Certification, Medical Device Regulation

In progress for an international certification in Medical Device Registration with the FDA, with expected completion in May 2026.

University of Pennsylvania

Specialization (Regulatory Compliance), Regulatory Compliance

2025 - 2026

International specialization in Regulatory Compliance, including FDA topics such as 21 CFR, classification, 510(k), PMA, and PMS; completed 2025 to 2026.

Massachusetts Institute of Business (MIB)

Master of Business Administration, International Trade Management

2023 - 2024

MBA in International Trade Management, completed from 2023 to 2024.

Medtronic (Global DRM)

Green Belt Training, Global DRM

2025 -

Green Belt training for Global DRM, completed in 2025.

University of La Verne

Certificate (International Course), Leading & Coaching the Human Organization

2024 -

International course in Leading & Coaching the Human Organization, completed in 2024.

Massachusetts Institute of Business (MIB)

MBA in International Trade, International Trade

2023 - 2024

Completed an MBA in International Trade at MIB in Cambridge, MA from 2023 to 2024.

Libertas Faculdades Integradas

Bachelor of Arts, Business Administration

2012 - 2015

B.A. in Business Administration, completed from 2012 to 2015.

Libertas Faculdades Integradas

Bachelor’s Degree in Business Administration, Business Administration

2012 - 2015

Completed a Bachelor’s Degree in Business Administration at Libertas Faculdades Integradas in Minas Gerais (MG), Brazil from 2012 to 2015.

ELS Language Centers

Business English Certification, Business English

Certification of Business English (date not specified).

University of Pennsylvania

International Specialization in Regulatory Compliance, Regulatory Compliance

2025 - 2026

Completed an International Specialization in Regulatory Compliance at the University of Pennsylvania from 2025 to 2026, covering FDA 21 CFR requirements and ISO 13485/14971.