#74 Navigating Regulatory Affairs with Kristen Mittal: Global Challenges, Breakthrough Devices and Career Insights

Kristen Mittal, Founder & CEO of Mittal Consulting a seasoned expert in regulatory affairs with over a decade of experience in the field. Kristen’s expertise spans across global regulatory challenges, innovative pathways and mentorship in quality and regulatory careers In this episode, we dive into why regulatory affairs is a rewarding yet complex career path, explore innovative programs like the FDA’s Breakthrough Device Designation and Total Product Lifecycle Advisory Program, and discuss the importance of harmonizing global standards in medical device submissions. Kristen also shares insights into the evolving landscape of sectors like pediatric devices, FemTech and AI/ML in medical technology Timestamps: [00:00:20] Rewards of a Regulatory Career [00:01:53] Key Qualifications for Regulatory Success [00:08:21] EU vs. USA Regulatory Pathways [00:10:30] Understanding Pre-Submission and 513G Processes [00:14:09] Designing Clinical Studies for Global Approval [00:21:49] Emerging Trends: Pediatric Devices and FemTech [00:25:33] Breakthrough Devices and Total Product Lifecycle Advisory Program Get in touch with Kristen Mittal - https://www.linkedin.com/in/kristenmittal/ https://www.mittalconsulting.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwal Subscribe to the Podcast