Rise of the Regulatory Rebel

In the Season 1 finale, Michelle and Ti challenge the traditional view of regulatory affairs as the “business prevention department.” Instead, they reframe regulators as strategic partners and proactive innovators who can drive compliance and competitive advantage. From shocking stories of last-minute compliance scrambles to major recalls that reshaped the industry, this episode reveals why being a “regulatory rebel” means understanding intent over letter, pushing back when it matters, and building trust across teams. Key takeaways: How proactive vs. reactive compliance impacts company culture and patient safety Why draft guidance matters (and how to use it to influence FDA thinking) The ethical and strategic case for regulatory professionals as innovators What Michelle and Ti would change if they ruled the FDA for a day Perfect for regulatory pros, quality leaders, and anyone ready to challenge the status quo in medtech. Season 2 coming soon!

You can listen to Rise of the Regulatory Rebel online on Radio and Podcast. Open the player on this page to stream the available audio.

Rise of the Regulatory Rebel is an episode from RA/QA Today by RAQA Today.

This episode is 00:39:46 long.

This episode was published on Sep 23, 2025.

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