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Lilly Mercado Location
Tarpon Springs, FL, US
Lilly Mercado Work
Manager of Regulatory Affairs and Quality Assurance @ (April 2024 - Present)
Sr. Regulatory Affairs- LATAM and MEA-Consultant @ (November 2023 - March 2024)
Sr. Regulatory Affairs Consultant @ (October 2022 - March 2023)
Quality Regulatory Affairs Specialist and Quality Compliance and QMS Programs Consultant @ (September 2019 - September 2022)
Regulatory Affairs Specialist @ (April 2019 - October 2019)
Senior Principal Specialist Consultant @ (March 2018 - December 2018)
Regulatory Affairs Specialist Consultant-IVD @ (August 2017 - March 2018)
Clinical Product Complaint Specialist @ (December 2016 - July 2017)
Regulatory Affairs Specialist @ (May 2014 - July 2016)
Lilly Mercado Education
Dominican University
Bachelor's degree (Biology, General)
Lilly Mercado Skills
510(k)
Adverse Events
Agile Methodologies
Analytical Skills
Authored Clinical Evaluation Report
Complaint Management
Compliance Training
Databases
Device Classification Evaluation
Distribution Quality
EU MDR
EU MDR Submissions
EU MDR Template
Employee Training
GMDN code analysis
Gap Analysis
Hold/Recall Impact Assessments
ISO 13485
IVD
Internal Audits
International Submissions: LATAM, APAC, MEA
LATAM submissions
Language Skills
Leadership
MDD
Medical Device Directive
Medical Devices
Microsoft Excel
Microsoft Office
Microsoft PowerPoint
New Product Development Team
Oral Communication
Presentations
Problem Solving
Product Change Notification Assessments
Product Labeling
Product Quality
Project Management
Project Management/SME
Quality Assurance
Quality Auditing
Quality Metrics/ Reporting
Regulatory Affairs
Regulatory Process Improvement Projects
Regulatory Requirements
SOP Authoring
SaMD
Strategy
Supplier Quality
Supplier Quality Agreements
Team Building
Technical Documentation
Training and Onboarding
Writing
Lilly Mercado Summary
Lilly Mercado, based in Tarpon Springs, FL, US, is currently a Manager of Regulatory Affairs and Quality Assurance at HARPS GLOBAL. Lilly Mercado brings experience from previous roles at Cook Medical, Medtronic, Cardinal Health and Arthrex. Lilly Mercado holds a Bachelor's degree in Biology, General @ Dominican University. With a robust skill set that includes 510(k), Adverse Events, Agile Methodologies, Analytical Skills, Authored Clinical Evaluation Report and more. Lilly Mercado has 2 emails and 1 mobile phone numbers on RocketReach.
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