Isabella Schmitt | AI & Regulatory Affairs Leader | Strategic Communication, Navigating Pre-Subs, & the Power of Mentorship

Isabella Schmitt is a prominent life science, AI, and regulatory affairs leader, and was recently named one of the top 100 MedTech Leading Voices Worth Following on LinkedIn in 2025. Isabella shares her diverse career journey—from aspirations of neurosurgery to becoming a regulatory expert in MedTech and biotech. She emphasizes the importance of early regulatory involvement, strategic use of pre-submissions, and understanding the voice of the customer in product development. Isabella also discusses the critical role of communication skills in regulatory affairs and offers invaluable advice for aspiring professionals.

 

Guest links: https://www.linkedin.com/in/isabella-j-schmitt/

Charity supported: Polaris Project

Interested in being a guest on the show or have feedback to share? Email us at [e-mail]. 

PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium

 

EPISODE TRANSCRIPT

Episode 048 - Isabella Schmitt

[00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world.

[00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them.

[00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives.

[00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives.

[00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives.

[00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.

Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey. And today I am so excited to introduce you to my guest, Isabella Schmitt. Isabella is a life science, artificial intelligence and regulatory affairs leader with expertise in navigating the intersection of science, technology, policy, and innovation.

With a robust background in medtech and biotech regulations, she has contributed to over 200 projects ranging from hardware and software medical devices to AIML products. Isabella holds an MBA from Texas A& M and is pursuing advanced studies in AI management and policy at Purdue University. Known for her engaging communication style, she is a sought after speaker, author, and consultant on AI regulation and innovation.

All right. Well, welcome to the show, Isabella. I'm so excited that you're here.

[00:01:41] Isabella Schmitt: I'm excited to be here. I feel like it's been a long time coming as we just talked about a second ago. We've been needing to connect for a while so I'm glad we're finally getting to do it.

[00:01:50] Lindsey Dinneen: Me too! Well yes. Thank you for taking some time today. And I wonder if you would be willing to start off by sharing a little bit about yourself, your background and actually what led you to medtech.

[00:02:00] Isabella Schmitt: Yeah. So it's an interesting story because I actually have a