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
