- Evaluating the effects of new regulations on the medical device sector
- Providing guidance on creating and deploying efficient quality management systems
- Examining the careful balance between innovation and safety mandates
- Sharing approaches for conducting quality risk assessments and taking proactive measures
- Charting a future course for the medical device industry with best practices and learned insights
Dina Justice
Vice President, Regulatory Affairs
Terumo Medical Corporation
Dina is currently the Vice President of Regulatory Affairs for Terumo Medical Corporation where she oversees both US and global Regulatory Affairs. Prior to joining Terumo in 2008, Dina spent 17 years at the FDA as a reviewer and later a branch chief in the Division of Cardiovascular Devices. She also spent some time as a Sr. RA consultant prior to joining Terumo.
Dina holds a BS in Biomedical Engineering from The Catholic University of America and a Master of Business Administration from the University of Maryland.
Jessica Smith
Corporate Vice President, Global Quality and Chief Regulatory Officer
Integra LifeSciences
Jessica is currently the Corporate Vice President, Global Quality and Chief Regulatory Officer at Integra LifeSciences, based in Princeton, NJ. Integra is a ~$1.5B multinational company and global provider of neurosurgical solutions, regenerative technologies, and surgical instrumentation. Jessica oversees all global RA and QA activities and serves as a member of the Executive Leadership Team. In her tenure at Integra, Jessica transformed the non-centralized regulatory organization into a centralized, highly efficient organization. She oversees and supports global regulatory authority collaboration and regulatory strategies for U.S. Class I, II, and III products. She is also the executive sponsor for the company’s EU MDR program and oversees global QA activities including, but not limited to, design assurance, supplier reliability and validation, quality management system compliance, and post-market activities.
Prior to joining Integra, Jessica held leadership roles with increasing levels of responsibility in regulatory and clinical affairs for Hillrom, Becton Dickinson (BD), and CR Bard. Jessica is passionate about professional mentorship and has been an invited speaker for numerous industry medtech and women’s leadership forums. Jessica also serves on the University of Utah Board of Governors, Engineering Alumni Association Board, and Engineering National Advisory Council. Jessica holds a BSc in Civil Engineering, and a Masters of Engineering and PhD in Bioengineering.
Ian Purdy
Sr VP of RAQA
Intuitive Surgical
Shibu Korula
EVP, Quality & Regulatory
Tecomet
Shibu joined Tecomet in August of 2021 as the Vice President of Quality Assurance and Regulatory and was promoted into his current role in August 2023. He is an experienced leader with over 20+ years’ experience successfully building and leading Quality and Regulatory teams in the medical device industry and is committed to assuring exceptional customer outcomes are achieved. Shibu is responsible for developing, leading and driving the strategy/execution of global quality, regulatory, while partnering with business leaders in obtaining world class customer experience and operational excellence.
Prior to joining Tecomet, Shibu lead the Regulatory Affairs and Quality Assurance at Lincotek Medical, Nanthealth, Endo Pharmaceuticals and Stryker in roles of increasing responsibility.
Shibu graduated from Florida International University with a Bachelor of Engineering Degree and a Master’s of Science in Mechanical Engineering Degree.
