Bruce Prothro

Bruce Prothro is a seasoned medical device professional with over 30 years of experience in the industry. He currently serves as the Senior Vice President of Global Regulatory Affairs at Penumbra, Inc., a position he has held since July 2021.1

Professional Background

Bruce's career spans various roles in regulatory affairs, quality systems, and operations management. His expertise includes:

• Developing and executing regulatory strategies for US, European, and global markets
• Interacting with FDA and other regulatory agencies
• Implementing quality management systems
• Leading clinical studies
• Building and managing global teams
• Overseeing operations, supply chain, and manufacturing processes1

Previous Positions

Before joining Penumbra, Bruce held several notable positions:

• Vice President of Regulatory Affairs and Quality at SI-BONE, Inc. (2019-2021)
• Vice President of Global Regulatory Affairs at Smith & Nephew (2014-2016)
• Chief Regulatory Officer and Senior Vice President of Quality Systems and Assurance at ArthroCare Corporation (1998-2014)1

Entrepreneurial Ventures

In addition to his corporate roles, Bruce is also an entrepreneur:

• Owner and Winemaker at Prothro Family Wines (2016-present)
• Principal at Prothro Consulting Group (2016-2019)1

Skills and Expertise

Bruce is known for his strategic approach to medical device development and regulatory compliance. He has experience in:

• Product clearances and registrations
• Commercialization strategies
• New product development
• Regulatory intelligence
• Quality assurance
• Medical affairs1

Bruce Prothro's diverse experience in both large multinational companies and startups, combined with his entrepreneurial spirit, makes him a well-rounded professional in the medical device industry and global regulatory affairs.