In this episode of The Med-Tech Talent Lab podcast, host Mitch Robbins interviews Mary McNamara-Cullinane, Vice President of Regulatory Affairs at ClearPoint Neuro, about her 25+ year journey in the medical device regulatory space.

Key Highlights:

• Mary shares her background as the youngest of eight children and how her early work ethic shaped her career path
• Learn how Mary transitioned from research to regulatory affairs through roles at Brigham and Women's, CRBARD, and a 17-year consulting career
• Discover what makes an outstanding regulatory professional in today's environment
• Understand the challenges regulatory executives face when balancing company goals with regulatory requirements

Practical Takeaways:

• Why proactive research and understanding the "why" behind regulations separates exceptional regulatory professionals
• The importance of managing leadership expectations around FDA timelines
• Why submitting complete FDA submissions is more efficient than rushing deficient ones
• Thoughts on remote work effectiveness in regulatory roles

Mary also discusses ClearPoint Neuro's exciting work with gene therapy companies and their recent partnership with PTC Therapeutics to address rare diseases in children.

Whether you're a regulatory professional looking to advance your career or an executive trying to better understand the regulatory landscape, this conversation offers valuable insights from a seasoned industry leader.

Mary McNamara-Cullinane on LinkedIn: https://www.linkedin.com/in/marymcnamaracullinane/

ClearPoint Neuro on the web:

https://www.clearpointneuro.com/