Jeff Smith

Serial medtech founder & CEO, Jeff Smith, interviews entrepreneurs leading the next wave of healthcare innovation. Jeff and guests share their experience building the products, teams, and businesses tackling healthcare’s UNMET NEED. read less

#7 - Solving FDA Regulatory Puzzles w/ Roxanne Dubois
Jun 19 2020
#7 - Solving FDA Regulatory Puzzles w/ Roxanne Dubois
Roxanne Dubois has represented medical device companies as the primary liaison with the FDA and Notified Bodies for over 25 years.  Roxanne forms collaborative working relationships with representatives of regulatory agencies to obtain clearance/approval for 510(k)s, IDEs, PMAs, and Design Dossiers for new medical devices and device modifications. Roxanne has hands-on experience writing regulatory applications (including three Original PMAs), responding to Agency questions and meeting in-person and by teleconference with FDA representatives. Roxanne’s experience also includes initiation of Quality Systems for start-ups, approval of new manufacturing facilities and facilitating on-site inspections by Regulatory Agencies (QSR, BIMO, pre-PMA, new facility and inspections by Notified Bodies and a Competent Authority). While mostly focused on Regulatory and Quality, she also has experience with Clinical Affairs and combination products.Roxanne has served as the VP of Regulatory Affairs and Quality at SI-BONE, VP of Regulatory Affairs at Tenaxis Medical, VP Regulatory Affairs and Quality Assurance at Carbylan BioSurgery, Inc., VP Regulatory Affairs, Clinical Research and QA at ReGen Biologics and also as the Director of Regulatory Affairs at several mid-sized companies including Kyphon, Collagen Corporation and Cohesion Technologies.  She has also consulted for medical device companies in a variety of fields such as orthopedic, gastroenterology, women’s health, dental and cosmetic surgery.  Roxanne has a Bachelor of Science in Biochemistry from Cal Poly, San Luis Obispo.Roxanne's Contact information:m: 408-828-5019e: rduboisconsulting@gmail.com