As a Principal Consultant, Sherry brings significant experience to MRC Global with a background working with small venture capital backed medical device companies in quality and regulatory management. She has implemented quality systems in regulated industries interfacing with domestic and international customers and regulatory bodies in support of all classes of devices including a BLA Class III combination device and PMA Type III active implantable medical device.
Prior to MRC Global, Sherry spent over 20 years in both Quality and Regulatory in various FDA regulated industries with the last 10 plus years in the medical device and biologics industry. In Quality, she was responsible for management of the quality system including internal and external auditing and audit preparation, risk management, complaint investigations and reportability decisions, supplier controls, training, change control, quality system set-up and assessment. In Regulatory, she was responsible for establishment registrations, preparation of international submissions, regulatory release of products, post market regulatory assessments, promotional material review, product labeling including electronic labeling, and international registrations.
Sherry received her Bachelor of Science and Master of Science at North Dakota State University with a concentration in Chemistry, Industrial Food Safety Concerns, Etiology/Food Borne Illness, and Economic & Regulatory issues concerning food safety.