Smith & Nephew, Inc.
Carolyn Shelton, Head of Regulatory Affairs | Advanced Surgical Devices Division

Carolyn Shelton has over 21 years of experience in Regulatory Affairs, Regulatory Compliance and Quality. Carolyn currently serves as Head of Regulatory Affairs for Smith & Nephew’s Advanced Surgical Device Division. This division was formed through the merger of their Orthopaedic business with their Endoscopy business. The scope of her work covers orthopaedic reconstruction and trauma, endoscopy (which includes arthroscopic procedures referred to as sports medicine). Carolyn provides leadership and guidance in the areas of domestic and international regulatory strategy, regulatory compliance and quality strategies to support 510(k), IDE, PMA, Custom Device, Compassionate Use and HDE submissions for class I, II and III devices and combination products. Smith & Nephew is a global medical technology business dedicated to helping improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma, Smith & Nephew has almost 11,000 employees and a presence in more than 90 countries. Annual sales in 2011 were nearly $4.3 billion.