We are Experts. We are Professional. We Roll-Up our Sleeves. We Drive Results in all Stages of Growth…from Concept to Commercialization.

Bruce founded Prothro Consulting Group after 28 years of proven success working with venture backed, mid-sized, and large medical device companies. For the past 18 years, he has held executive level leadership positions, including Vice President, Global Vice President, and Chief Regulatory Officer, for rapidly growing entrepreneurial based and large multi-national corporations. In this capacity, Bruce has led regulatory affairs, quality assurance, quality systems management, clinical research, and medical affairs functions while managing organizations ranging from just a few individuals to global networks in excess of 200 people. In addition, he has experience in operations and manufacturing management, general management for surgical products, and has built and validated facilities in both the United States and Latin America.

Throughout his career, Bruce has leveraged his breadth of experience to help companies drive to practical, well thought-out solutions that complement both regulatory and compliance objectives along with commercial initiatives. This background makes Bruce truly unique among regulatory and quality professionals.

Strategic, Hands-On, Pragmatic, Thorough, Solutions-Oriented, Collaborative, Professional, Composed, Responsive, Hard Working, Efficient.

These are a just few of the adjectives used to describe Bruce during his career and the very same attributes that lead to well-designed, well-crafted solutions in the ever-changing environment of regulatory affairs, quality assurance, compliance, and clinical research.

Under his leadership and guidance, Bruce’s organizations have:

  • Obtained registrations in over 60 markets including Latin America, China, and Japan
  • Submitted over 1,700 registrations and renewals annually for emerging markets
  • Developed and implemented quality management systems for small and mid-size companies
  • Managed over 30 FDA and notified body inspections without a warning letter or major observations
  • Developed clinical strategies to support new indications
  • Developed submission strategies in over 14 surgical specialties
  • Supported class I, class II, and class III devices
  • Submitted over 140 510(k)s
  • Obtained a 98% clearance rate
  • Guided complex and unique PMA submissions
  • Developed and executed FDA submission strategies for the reintroduction of products in the US market
  • Executed BLAs and strategies for combination devices
  • Managed over 100 technical files and dossiers for EU commercialization

In addition to his work in regulatory affairs, quality assurance, operations, and clinical research, Bruce has developed strategies to mitigate risks of off-label promotion, served on corporate compliance committees, and contributed to the mitigation and resolution of issues arising from SEC and DOJ investigations. He has developed and led global complaint management, MDR and Vigilance reporting, corporate audit functions, and implemented UDI across a global network. He has presented at various conferences nationwide on regulatory and quality assurance challenges and has represented companies in litigation as a company designated expert witness.

Bruce’s career in medical devices started at Advanced Cardiovascular Systems and progressed to KervaVision, ArthroCare, and Smith & Nephew. He has participated in initial and secondary public offerings, acquisitions and mergers, and was part of the leadership team that steered the $1.7B acquisition of ArthroCare by Smith & Nephew.

Bruce holds a Bachelor of Science in Chemistry from University of California, Berkeley where he also played football.