Vice President, Regulatory Affairs

Del Stagg, PhD, provided product development and regulatory guidance for ~ 45 years to biotechnology, pharmaceutical and medical device companies. He has worked at both large and small medical product companies throughout that time and was instrumental in coordinating with Regulatory Agencies to develop and bring new products to the market in the Americas (North, Latin and South America), Europe, Asia Pacific and other countries to help patients with serious medical conditions. In addition to developing products for larger companies, he helped four small companies successfully bring their first medical product to market.

• Expertise and experience in medical product (biologics, devices, and pharmaceuticals) development and registration with Ministries of Health on a global basis.
• Expert for testing of medical products and developing international standards for such tests (pharmacology, toxicological, biocompatibility and safety).
• 1998 Recipient of the FDA Commissioner’s Special Citation “For outstanding leadership and commitment in furthering FDA’s efforts to provide the consumer and the regulated industry with a more responsive Agency.”

In addition to his responsibilities within the companies for which he worked, Dr. Stagg has held various other industry and professional leadership roles important to the community and medical products industry including: 1) Member of the Board of Directors for the Discovery Science Center in Santa Ana, California, since 2003; 2) Chairman for the Southern California Pharmaceutical Discussion Group from 1997-1999; 3) President of the Orange County Regulatory Affairs Discussion Group in 1996-1997; 4) Industry Representative to the FDA/Industry Regulatory Grassroots Partnership from 1996-1998; 5) Co-Founder for the Orange County Regulatory Affairs Discussion Group in 1993: 6) Co-Founder and Chairman, North Carolina Regulatory Affairs Forum in 1992; and 7) Co-Chairman for the US-Sub Technical Advisory Group and US representative to the International Standards Organization Group 10-993, Biological Evaluation of Medical Devices from 1988-1997.