Kathy L. Remsen, MS, MBA, CTBS
Ms. Remsen has over 20 years of experience in the areas of Product Development, Quality Assurance, and Regulatory Affairs of injectable drugs, implantable medical devices, combination products, and tissue products.
Before joining MRC-X, Kathy was a Senior Program Manager of Regulatory Affairs at Medtronic Inc. where she was responsible for U.S. and global regulatory filings with respect to the company’s class I, class II, and class III medical devices and combination products. Kathy was also involved in the development and early-stage clinical testing of controlled-release drug depots. Kathy is co-inventor of 18 U.S. patents and several U.S. patents pending. Kathy holds a Bachelor’s degree in Chemistry from Rhodes College and a Master of Science degree in Organic Chemistry from Vanderbilt University.
Before joining MRC|X, LLC, Ann spent over 12 years working at Medtronic Spinal and Biologics in both Quality and Regulatory. In Quality, she was responsible the 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. She 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.
Maris Garner, CTBS, CQA
Before joining MRC|X, LLC in 2016, Maris spent 12 years in different roles within the medical industry including working as a Registered Nurse in the Intensive Care Unit (ICU) of a major hospital, serving as a Clinical Educator for C.R. Bard, Compliance Audit Manager at Medtronic Spinal and Biologics and most recently medical device consulting. While at Medtronic she primarily focused on HCT/P based products regulated under 21 CFR 1271 and 21 CFR 820. She was responsible for developing and maintaining a Quality System, internal and external audits, tissue licensing and registrations, state annual reporting, training programs, interfacing with FDA and state agencies, as well as conducting due diligence and integration activities for acquisitions. She gained experience managing HCT/P distribution activities from recovery to customer both directly and as an intermediary.
Maris received a Bachelor of Science in Nursing from Mississippi University for Women. She is a Certified Tissue Bank Specialist through The American Association of Tissue Banks (AATB) as well as a Certified Internal Auditor through the American Society for Quality (ASQ).
Before joining MRC X, LLC in 2017, Theresa spent 14 years in the medical device industry working with mid- and large-sized companies. She focused on regulatory strategy and submissions, along with clinical study design and study execution, for orthopedic devices used in procedures such as total hip arthroplasty, total knee arthroplasty, spinal fusion, spinal disc replacement, and small bone plating systems.
Theresa received a Bachelor of Science in Mechanical Engineering from Christian Brothers University in Memphis, TN.
Prior to joining MRC-X, LLC, Teresa spent over 20 years in the medical device industry leading and managing quality systems in global companies such as Baxter, Becton and Dickinson, Bard, Christie Medical and FedEx Supply Chain. During her career, Teresa has had the opportunity of performing different roles within the quality organization leading Quality Engineers, Laboratory Personnel and Quality Specialists and providing guidance to ensure compliance with applicable regulatory requirements. Teresa’s areas of expertise include CAPA process, quality audits, document control, supplier management, complaint handling, environmental monitoring, laboratory operations, gamma and EO sterilization, and calibration systems.
Teresa received a Bachelor of Science from the University of Puerto Rico. In addition, she completed a Professional Engineering course from The George Washington University at Washington DC. She has also obtained continual education credits from the College of Chemists of Puerto Rico and a Six Sigma Engineer Certification from Baxter Institute. She is bilingual (Spanish and English).
Before joining MRC|X, LLC in 2013, Jen McBride worked at Medtronic Spinal and Biologics in Regulatory, where she was responsible for regulatory assessments, 510(k) submissions, technical files, and international registrations. Since joining MRC|X, LLC, Jen has continued to be responsible for regulatory assessments and 510(k) submissions, while also expanding her knowledge of quality systems through compliance remediation activities for design history files and technical files. Jen received a Bachelor of Science in Biology from the University of Memphis.