ABOUT US

KAREN L. RICHARDS

Vice president, REGULATORY

  • As Vice President of Regulatory Affairs, responsible for driving the development of new IVD products in compliance with regulatory requirements
  • Extensive experience with global regulatory submissions and approvals covering multiple technologies and disease conditions
  • Successful implementation of quality management systems in compliance with global quality standards
  • Proven track record with driving regulatory strategies to successful market entry for multiple diagnostic companies over a 30+ year career
  • Developed and implemented regulatory initiatives to support both laboratory-based and traditional IVD operations
  • Currently employed by Precision for Medicine as SVP of IVD Regulatory and Quality Consulting, and acting as a consultant to Mainz Bio in the Regulatory Affairs role 

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