Pamela Weagraff

Pamela Weagraff

Quintiles

Senior Scientist

Ms. Weagraff leads Quintiles’ Medical Device & Diagnostics Regulatory Science team. Ms. Weagraff and her team deliver strategic and tactical consulting services to ensure appropriate linkages between regulatory plans, clinical plans, and business strategy; develop and manage regulatory authority communication plans, serve as liaisons on behalf of clients with regulatory authorities; conduct assessments of product and labeling-related compliance programs; and assist clients with commercialization planning. Prior to joining the consultancy ranks, Ms. Weagraff had been bringing medical devices through product development to market in a variety of start-up, mid-size and large companies such as Hewlett Packard’s Medical Products Group (now Philips Healthcare) for over 25 years. Ms. Weagraff has been a key contributor to the development and implementation of the company business strategies, including regulatory, clinical and early stage marketing, and product management strategies. Ms. Weagraff has extensive international experience from working and living in the EU and travels to the Asia Pacific region. She combines a unique mix of marketing and regulatory expertise in the development and implementation of customer-focused strategies. Known for a collaborative approach with regulatory agencies, Ms. Weagraff integrates regulatory requirements to inform but not drive the business strategy. Ms. Weagraff has been recognized for her contributions to industry/FDA initiatives at the national and regional level and invited to lecture on a variety of FDA issues for industry organizations. In addition to her appointment as HIMA (now AdvaMed) Management Fellow, Ms. Weagraff was also recognized as an AdvaMed Achiever and received Vice President Al Gore’s Hammer Award from the National Partnership for Reinventing Government. Ms. Weagraff holds a Bachelor of Arts from Pennsylvania State University, Phi Beta Kappa, and a Masters of Business Administration, from Boston University.