As a Principal Consultant, Ann brings nearly 30 years of healthcare experience to MRC Global with an extensive career that includes spine and biologics regulatory and quality management, medical equipment (hardware/software) validation, medical equipment engineering (diagnoses/repair), as well as clinical immunology. She is a seasoned expert in medical device quality and regulatory affairs, including the development of quality systems, protocols and regulations for the world’s largest medical device manufacturer. This includes a highly unique skillset combining strategic vision with an engineering mindset and mechanical aptitude.
Prior to MRC Global, Ann spent over 12 years working at Medtronic Spinal and Biologics in both Quality and Regulatory. In Quality, she was responsible for management of the quality system including external audits, internal audits, CAPA, training, management review, document control, and change control. In Regulatory, she was responsible for establishment registrations, regulatory release of products, post market regulatory assessments, promotional material review, product labeling including electronic labeling, and international registrations.
Ann also worked for Alpha Therapeutics where she authored and executed validation protocols for freezers, refrigerators, document control systems, water systems, immunoassay analyzers, computer hardware, and software. Ann has experience as a field service engineer with Abbott Diagnostics installing and repairing hematology, chemistry, and immunology analyzers in hospitals and physician offices.
Ann started her professional career as a Medical Technologist working in clinical immunology labs at The Regional Medical Center and Methodist Healthcare in Memphis after receiving her Bachelor of Science in Medical Technology from The University of Memphis.