Becky Ditty joined Biologics Consulting in the spring of 2017 with over 14 years of industry experience in medical device regulatory affairs. Prior to joining Biologics Consulting, Becky integrated regulatory strategy throughout the product lifecycle supporting the creation of new product development including labeling, risk management, premarket submissions, and change control. Becky supported a diverse product portfolio, including bone cements, computer assisted surgery systems, vertebral balloon systems, and radiofrequency generators; along with the integration of acquired products. Becky was an active participate in the AdvaMed software work group, which collaborated with FDA to develop the new software-focused guidance document "Deciding When to Submit a 510(k) for a Software Change to an Existing Device".
From a post-market compliance perspective, Becky supported post-market surveillance activities including managing medical device reports (MDR) filings and device recalls. Additionally, Becky led the internal audit program and regularly assisted in third party audits.
Furthermore, Becky was an account manager for division-wide regulatory affairs and quality (RA/QA) projects. As the account manager, Becky was the liaison between the regulatory and quality departments and the IT department. Becky managed the implementation of new IT solutions and the modifications to existing systems to better meet the RA/QA department needs.
Becky earned a bachelor of science in management information systems and marketing from Oakland University. She later earned a master of science in Orthopedics Regulatory and Clinical Affairs from Grace College and Seminary.
BS, Management Information Systems, Marketing, Oakland University, Rochester, MI (1999)
MS, Orthopedic Regulatory and Clinical Affairs, Grace College and Seminary, Winona Lake, IN (2013)