Regulatory Affairs Specialist

Our lead regulatory specialist has over 28 years of industry experience and provides strategic, hands-on solutions for regulatory, quality assurance, and compliance challenges along with support and expertise in clinical research and operations. For the past 18 years, our specialist 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. 

Our specialist has worked in all major surgical specialties and includes experience ranging from class I to class III, spanning the United States to over 60 countries, covering small to large markets, and encompassing 510(k) to PMA to technical files and dossiers. Our specialist has successfully negotiated with FDA, Competent Authorities, and other international regulatory agencies. 

Key Accomplishments Include:

  • 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 

Technology Expertise Includes:

  • Wound Care
  • Gynecology
  • Plastic and Reconstructive Surgery
  • Neurosurgery
  • Skin Resurfacing
  • Soft-Tissue Ablation
  • Tissue Fixation
  • Visualization Systems
  • Cardiovascular
  • Orthopedics
  • Ophthalmology
  • Sports Medicine and Arthroscopy
  • Ear, Nose, and Throat
  • General Surgery
  • Urology