Background
Melissa Smallwood is a professional Regulatory Affairs strategist with over 10 years of experience in Regulatory Affairs and Global Regulatory Body Communications. Melissa has worked on a wide range of products, including radiofrequency ablation, implantable LAA closure devices, cryotherapy indicated for pain relief during her time at AtriCure, Inc., and numerious exchanges at MCRA, including cardiovascular and circulatory support, electrophysiology and RF ablation devices, general surgery, neurosurgical, and denervation projects.
Education
Melissa received her college education at Franklin University in Applied Science receiving a Bachelor of Science in Healthcare Management and a Master’s of Healthcare Administration, MHA.
Experience
Previously, Melissa spent 7 years at AtriCure, Inc. managing and supporting Regulatory Strategy, total product life cycle change assessment and engagements with FDA, Pre-submission, 510(k) applications, PMA Supplements and PMA development, Clinical Study development with IDE applications, and world-wide Regulatory stategy and assessments for various countries.
Overview
At MCRA, Melissa leads and executes Regulatory strategies, technical submission development, project management, and communications with FDA applications. These engagements have helped MCRA clients to streamline costs and timelines on a broad scope of projects. Melissa has led or supported projects including 510(k)s, Pre-Submissions, DeNovos, Investigational Device Exemptions (IDE), and Premarket Approval (PMA)s for class I-III medical devices.
Melissa’s professional focus is to understand the needs of each individual client, based on her experience in industry, and to bridge the gap for successful engagements with FDA.