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Content provided by Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Michelle Lott or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
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Rise of the Regulatory Rebel

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Manage episode 508136477 series 2446473
Content provided by Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Michelle Lott or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

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  • Why draft guidance matters (and how to use it to influence FDA thinking)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!

  continue reading

57 episodes

Artwork
iconShare
 
Manage episode 508136477 series 2446473
Content provided by Michelle Lott. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Michelle Lott or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

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!

  continue reading

57 episodes

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