Karen Piloto Ruvalcaba in

Karen Piloto Ruvalcaba

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Director, Global Device Vigilance & Safety Reporting at Alcon
📍 Dallas-Fort Worth Metroplex, United States

Karen Piloto Ruvalcaba is the Director, Global Device Vigilance & Safety Reporting at Alcon, specializing in ophthalmic medical devices, clinical experience, and global regulatory compliance. She holds an MBA from Texas Womans University and has strong skills in quality checks, project management, and cross-functional collaboration.

Outside of her corporate role, Karen is a professional artist represented by the Haley-Henman Art Gallery since 2007, creating modern expressionist and abstract art. She is bilingual in Spanish and English and is passionate about art and continuous learning.

Unique fact: Karen has been a professional artist for over 15 years, showcasing her work in various exhibitions.

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Experience
32 Years
Current Role
Director, Global Device Vigilance & Safety Reporting
Job Level
Mid-senior
Location
Dallas-Fort Worth Metroplex, United States
Personality Overview

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Priorities

Topics Karen cares about

Medical Device Safety
As Director, Global Device Vigilance & Safety Reporting, Karen is deeply involved in regulatory compliance and adverse event reporting for ophthalmic devices.
Global Regulatory Compliance
Her roles at Alcon have consistently involved FDA and global regulatory compliance, assessments, and reporting for medical devices.
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Career

Work history

1-2025
Director, Global Device Vigilance & Safety Reporting
Alcon
1-2020 - 1-2025
Sr. Manager, Global Device Vigilance MS, Surgical
Alcon
9-2017 - 12-2019
Sr. Manager, Global Device Vigilance, MS, Vision Care
Alcon Labs a Novaris Co.
1-2012 - 9-2017
Medical Safety Specialist, Regulatory Reporting for Instrumentation and Custom Packs.
Alcon Labs a Novartis Co.
8-2000 - 12-2011
Certified Ophthalmic Technician, Refractive Surgery Tech, Patient Education LASIK/Refractive IOLs
UT Southwestern Medical Center at Dallas
In the press

Media appearances

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Education
2014 - 2017
Master of Business Administration (MBA)
Texas Woman's University
Bachelor's degree in Visual Arts
UTD
Social presence
in
Behavioral profile

DISC profile (public)

DISC behavioral profile

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