Tim Ulatowski, Former Director of the Office of Compliance at FDA’s Medical Device Center, Joins Becker & Associates Consulting as Director of Expert Advisory Committee

WASHINGTON--(BUSINESS WIRE)--Becker & Associates Consulting, Inc. (BECKER CONSULTING), is proud to announce the addition of Tim Ulatowski, former Director of the Office of Compliance within the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), as Director, Medical Devices on the BECKER CONSULTING Expert Advisory Committee. Mr. Ulatowski brings both significant pre-and post-market regulatory compliance expertise to the firm, and is available immediately to provide strategic guidance to FDA-regulated companies and their counsel.

“We are privileged to have Tim Ulatowski as a Director on our Expert Advisory Committee, and are confident that our clients will benefit from his extensive FDA and industry experience with medical device compliance issues.”

Mr. Ulatowski has over 36 years of public health experience, including more than 25 years in multiple leadership positions at FDA’s CDRH. In addition to most recently serving as Director of the Office of Compliance at CDRH, where he managed and supervised four divisions consisting of 180 staffers responsible for ensuring compliance with medical device laws and regulations, Mr. Ulatowski has also served as a primary reviewer on numerous 510(k) premarket notifications, investigational device exemptions, and premarket approval applications. He also managed premarket activities as Director of the Division of Dental, Anesthesiology, General Hospital, and Infection Control Devices at CDRH’s Office of Device Evaluation (ODE).

As a Director with BECKER CONSULTING’s Expert Advisory Committee, Mr. Ulatowski provides guidance to the firm’s medical device practice in addition to developing tailored technical consulting solutions for clients. This role will capitalize on Mr. Ulatowski’s proven expertise advising industry on regulatory issues, assessing compliance and enforcement actions, evaluating premarket documents, facilitating collaboration among stakeholders with diverse interests, and resolving complex technical and scientific problems. Mr. Ulatowski shares the firm’s commitment to provide best-in-class expert support to medical device firms throughout the total product lifecycle, from product development through FDA approval to post-market compliance.

Ron Johnson, President of BECKER CONSULTING, explained, “We are privileged to have Tim Ulatowski as a Director on our Expert Advisory Committee, and are confident that our clients will benefit from his extensive FDA and industry experience with medical device compliance issues.”

About Becker & Associates Consulting

Becker & Associates Consulting, Inc., established in 2002, is among the leading scientific consulting firms in the United States. The Company specializes in guiding corporations through the clinical and regulatory process, and maintains perhaps the most highly regarded compliance practice for FDA-regulated products.