Michelle Lott

Regulatory Strategist, Principal and Founder

Professional Overview

Michelle Lott is a seasoned regulatory expert with over 15 years of experience in the medical device industry. As the Principal and Founder of Lean RAQA, LLC, she provides strategic regulatory guidance to organizations, helping them navigate complex compliance requirements and optimize their quality systems.

Experience Summary

Current Role

As the Regulatory Strategist, Principal and Founder of Lean RAQA, LLC, Michelle leverages her deep industry knowledge and technical expertise to deliver tailored regulatory solutions to her clients. She works closely with medical device companies to develop robust regulatory strategies, ensure compliance with FDA and international regulations, and implement effective quality management systems. Under her leadership, Lean RAQA has established a reputation for providing innovative, pragmatic, and cost-effective regulatory support.

Career Progression

Prior to founding Lean RAQA, Michelle held various regulatory and quality assurance roles, including serving as the Industry Representative on the Device Good Manufacturing Practices Advisory Committee (DGMPAC) at the FDA. She also held executive advisory positions at Cognition Corporation and leadership roles at Xeridiem (formerly MRI Medical) and Westmed Inc. Michelle's diverse background and hands-on experience have enabled her to develop a deep understanding of the regulatory landscape and the challenges faced by medical device manufacturers.

Academic Background

Michelle holds a Bachelor's degree in Chemistry from the University of Arizona, where she graduated with honors.

Areas of Expertise

• Regulatory strategy development and implementation

• Quality system design and optimization

• FDA and international compliance (e.g., ISO 13485, MDR, IVDR)

• Project management and process improvement

• Leadership and cross-functional collaboration

Professional Impact

As an industry representative on the DGMPAC at the FDA, Michelle played a crucial role in providing valuable insights and feedback on regulatory policies and guidelines. Her contributions helped shape the agency's approach to medical device good manufacturing practices, ultimately benefiting the broader industry.

Conclusion

With her extensive experience, technical expertise, and strategic mindset, Michelle Lott is a trusted partner for medical device companies seeking to navigate the complex regulatory landscape and achieve sustainable compliance. Her commitment to innovation and her ability to deliver practical solutions have made her a respected leader in the field of regulatory affairs and quality assurance.