Christine Scifert

MS, MEM

Partner

As Founder and Partner, Christine’s vision is the driving force behind our continued growth. Her leadership has made MRC Global a leading regulatory and quality systems consulting firm highly respected throughout the medical device industry. Christine’s extensive regulatory background has made her a sought-after resource by established medical device manufacturers and product development teams, as well as new device starts-ups and investors evaluating market potential. Leveraging her talent clients are able to identify regulatory hurdles, develop a more realistic launch protocol, and expedite market entry while significantly reducing expenses and maximizing resources.

Prior to MRC Global, Christine spent 11 years as a consultant with MRC-X, LLC and Memphis Regulatory Consulting and 9 years at Medtronic Spinal and Biologics directing the regulatory department of 22 people. As Senior Director, she set regulatory strategy, oversaw global submissions and developed a design control process. Christine interfaced directly with the FDA and notified bodies, overseeing the modification and implementation of all department procedures to maintain regulatory compliance while performing due diligence activities for potential acquisitions. Prior to Medtronic, Christine performed evaluations of injury mechanisms associated with automobile collisions, slip and falls, and sport/recreation accidents.

Christine received a Bachelor of Science in Physics from Hamline University and a Masters of Science in Biomedical Engineering from University of Iowa. She also completed a Masters in Engineering Management from Christian Brothers University. Christine is also an adjunct professor at Christian Brothers University teaching regulatory affairs and presents nationally as a regulatory expert at various trade shows/conferences.

Highlights
  • Partner with more than 20 years’ regulatory experience
  • Senior Director of Regulatory Department
    for Medtronic Spinal and Biologics
  • Nationally sought-after and highly respected regulatory expert
  • Masters in Engineering Management and Biomedical Engineering
  • Adjunct Professor Regulatory Affairs