Kathy L. Remsen

MS, MBA, CTBS

Principal Consultant

Memphis, TN

901-606-4856
Kathy.Remsen@AskMRCGlobal.com

As a Principal Consultant, Kathy brings more than 20 years of experience to MRC Global and has been a critical asset behind our tremendous success and continued growth. Her pharmaceutical, biologics and implantables expertise is extensive and significantly expands MRC Global’s broad reach into all life sciences categories.

Kathy’s background includes product development, quality assurance and regulatory affairs as an expert in the areas of injectable drugs, implantable medical devices, combination products, and tissues/biologics. She is also an experienced program manager and strong legal professional highly skilled in US Food and Drug Administration (FDA), Verification and Validation (V&V), Design Control, Corrective and Preventive Action (CAPA), and Medical Devices. 

Prior to MRC Global, Kathy was a Senior Program Manager of Regulatory Affairs at Medtronic where she was responsible for US 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 and is the co-inventor of 18 US patents and several US patents pending.

Kathy’s depth of experience and industry expertise is complimented by her extensive education that includes a Bachelor’s degree in Chemistry from Rhodes College, a Master of Science degree in Organic Chemistry from Vanderbilt University, and a Master of Business Administration from Union University. She is also a Certified Tissue Bank Specialist (CTBS).

Highlights
  • Principal Consultant with more than 20 years’ regulatory experience
  • Senior Program Manager of Regulatory Affairs at Medtronic
  • Co-inventor of 18 US patents and several US patents pending
  • Masters in Organic Chemistry
  • Masters in Business Administration
  • ISO 13485 Lead Auditor Certification