Women in Leadership Program Advisor

Lisa Maloney

Active Term: 11/2024 - 11/2025

Areas of Expertise

• Inspiring Emotional Intelligence
  
• Winning Work-Life Balance & Mentoring
  
• Organizational Leadership & Cultural Diversity

Director of Regulatory Affairs and Quality Assurance

Vertos Medical Inc

With over 25 years of experience in Regulatory Affairs and Quality Assurance for Class I, II, and III medical devices, Lisa brings expertise in regulatory strategy, quality system development, and international compliance. Known for a strategic and results-oriented approach, she has a proven record of leading successful regulatory submissions, including FDA PMA, 510(k), and IDE applications.

​Lisa has managed cross-functional teams, led M&A due diligence efforts, and driven quality improvements, achieving ISO 13485 certification, FDA inspection success, and Notified Body audit clearances. With a comprehensive understanding of regulatory standards and trends, she is a valuable resource for navigating regulatory challenges and market entry strategies. Education and Certifications: Executive Leadership Program (Kellogg School of Management), BA in Law & Society (University of California, Santa Barbara), Regulatory Affairs Certified (RAC-US), Certified ISO Lead Auditor; active member of OCRA and RAPS.