David is a passionate and driven leader, mentor, and subject matter expert with over a decade of regulatory and clinical experience in the medical device field, including nine years as an Acting Branch Chief, and Lead Medical Device Reviewer and Biomedical Engineer at the US Food and Drug Administration (FDA). His mission is to "provide a window into the FDA and the Center for Devices and Radiological Health (CDRH)," and help those responsible for regulatory affairs, both now and in the future, to optimally position their companies for success.
In his FDA Guidance Review and Medical Device Review video series, David is offering his seasoned perspective free to industry, to address the lack of readily available, digestible intelligence about the impactful new medical device guidance documents and other announcements coming out of FDA.
David's aspiration is to provide high-value (and even fun!) clarity and context on evolving FDA policies. Through his videos and other content, both seasoned regulatory affairs professionals and FDA staffers, and those looking to enter this critical field, can learn from his insights on how the agency works, and effectively communicate with FDA as they navigate the complex regulatory landscape to bring safe, effective, and transformative new products to people in need. Along with this, he is bringing together an engaged regulatory community, who have a critical role in driving the future of healthcare.
DAVID'S EXPERTISE INCLUDES:
Helping small startups successfully navigate FDA submissions;
Delivering results in high-visibility regulatory and quality roles;
Leading teams in reviewing hundreds of FDA submissions; and
Serving patients and physicians in surgical and clinical settings.
Senior Director, Regulatory/Quality, Ostomy
ConvaTec | Greensboro, NC | 2018 – Present
Director, Regulatory/Quality, Americas
ConvaTec | Greensboro, NC | 2017 – 2018
Lead Medical Device Reviewer, Biomedical Engineer
Food and Drug Administration (FDA), Office of Device Evaluation | Silver Spring, MD | 2008 – 2017
Acting Branch Chief
Implantable Electrophysiology Devices Branch
Food and Drug Administration (FDA), Office of Device Evaluation | Silver Spring, MD | 2015 – 2016
Congressional Affairs Specialist (Temporary Detail Assignment)
Food and Drug Administration (FDA), Office of Legislation|
Silver Spring, MD | 2015
Field Intern / Field Engineer
St. Jude Medical | Minneapolis/St. Paul, MN | 2006-2007
HBX, Harvard Business School
CORe: Credential of Readiness | Pass with High Honors
Boston, MA | September 2016
Johns Hopkins University
Master of Mechanical Engineering |Honors, 4.0 GPA
Baltimore, MD | December 2014
Case Western Reserve University
BSE in Biomedical Engineering | Cum Laude, 3.67 GPA
Cleveland, OH | May 2006