Sharon DeGrove Bishop, RAC

Sharon DeGrove Bishop, RAC has a lengthy and diverse work experience in the regulatory affairs field. Sharon started their career in 1989 as a Sr Regulatory Technical Specialist at Storz Ophthalmics and later moved on to become an Advanced Regulatory Affairs Associate at 3M in 1991, where they performed various US regulatory functions for class II and III devices. In 1992, they joined Storz Ophthalmics again as an International Regulatory Affairs Specialist, achieving ISO and QS certification for surgical devices and successfully registering products in multiple countries.

From 1997 to 2000, Sharon worked at Bausch + Lomb as a Regional Manager Americas, Regulatory Affairs. In this role, they established systems and processes for product registrations in the US, Canada, and Latin America, ensured regulatory compliance, and obtained CE/MDD compliance for class II and III products.

In 2011, Sharon joined Teleflex Medical as a Regulatory Consultant before moving to Graematter, Inc. in 2013, where they currently hold the position of Director of Regulatory Affairs. At Graematter, they are a certified regulatory affairs consultant to the medical device industry, utilizing their extensive regulatory experience in class I, II, and III devices. Sharon is also involved in providing advanced analytics using the SOFIE Regulatory Intelligence System, which aggregates and cross-references government regulatory databases for medical products.

Throughout their career, Sharon DeGrove Bishop, RAC has demonstrated expertise in various areas such as compliance, auditing, international regulations, product registrations, and quality management systems.

Sharon DeGrove Bishop, RAC, holds a degree in Chemical Engineering from Auburn University. In addition, they have obtained certifications in Regulatory Affairs. In December 2010, they achieved the RAC-US certification from the Regulatory Affairs Certification Program. Sharon also has a certification in Regulatory Affairs from the Regulatory Affairs Professionals Society (RAPS), although the specific details regarding the month and year of obtaining this certification are not available.