WIB-Seattle & ORCA: Regulatory Affairs Expert Panel

WIB Seattle had the honor of hosting a panel event with ORCA of Seattle. The panel included Regulatory Affairs experts in the region: Ali Bouge, Executive Director of Regulatory Affairs at Exegenesis Bio; Michael F Petrini, VP of Regulatory Affairs of Patient Care Solutions at GE HealthCare; Megan Duncan, Senior Manager of Regulatory Affairs at Guardant Health; and Mike Willingham, Director of Regulatory Affairs at Google Health.

Mike opened the discussion with his experience in medical devices and health software. He mentioned that online regulatory practices in healthcare have brought new challenges to the profession. New treatments, data storage, and generative AI quickly became much of the focus of the discussions. Bringing new methods of analysis and treatments can be a challenge for these specialists in ensuring regulations for safety are at the forefront of decisions. Mike mentioned that not all AI is created equal, especially in terms of how the data to produce results is curated. Working with the FDA becomes an undefined challenge because the regulations are not well defined.

The panelists were asked what motivated them to choose regulatory affairs. Megan had been inspired by the practicum she had completed through her program at the University of Washington. Ali had started her clinical research career and wanted to understand the “why” behind regulations. She loved reading about other products on the market. Michael agreed, saying he was always the one asking “the why.” Being curious about what made products successful was undoubtedly shared by the panelists.

Advice to those new in the field was to expand yourself in educational opportunities. Learn how to research a project, optimize your presentation skills for impact, and always follow through. Ali mentioned resilience is essential. You need to work with the agencies to navigate new opportunities, not shy away from them. Stay current, transparent, and vocal. Megan agreed that facing conflict is part of the role. Be comfortable working in the gray and open to discussion. Natural curiosity and investing in your education are key assets hiring managers look for in this field. 

Submitted by Margaret Kenrick