Maddie Tran, Associate QA/RA Consultant & Project Manager

Maddie Tran

ASSOCIATE QA/RA CONSULTANT & PROJECT MANAGER

Joined: February 23, 2026

Skills

ISO 13485 Lead Auditor; IEC 62304 Certified. Experience supporting compliance with FDA 21 CFR Part 820 (QSR/QMSR) ISO 14971 IEC 62366-1 and FDA SaMD guidance.

Bio

I am a quality and regulatory consultant with extensive experience supporting startup medical device companies developing cutting-edge technologies. I have worked across fast-paced development and commercialization environments, helping teams implement practical, scalable quality systems and regulatory strategies that align with FDA and ISO 13485 requirements.

I graduated from Drexel University with a Bachelor’s degree in Biomedical Engineering and a minor in Neuroscience. I am particularly interested in innovative medical device and digital health technologies and enjoy working on a wide variety of projects that bridge engineering, quality, and regulatory strategy.

Hobbies

Outside of work, I’m a certified yoga teacher, former competitive horseback rider, enthusiastic baker, and experimental home barista who loves exploring new restaurants and staying active.