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Marielle Lejcher, CORe-Credential of Readiness in Business from Harvard Business School (HBS)

Senior Regulatory Affairs Consultant
Fang Consulting

Marielle Lejcher, Senior Regulatory Affairs Consultant. With 20 years of experience in the medical device industry, Marielle has dedicated the last ten years to mastering the complexities of regulatory affairs. Her expertise spans a wide range of areas, including medical devices, in-vitro diagnostics, pharmaceutical drugs, telehealth, and digital health solutions. Marielle's primary areas of focus revolve around risk strategy, biocompatibility, EU MDR regulation, and FDA policy.

Marielle’s educational journey began with a Bachelor of Science in Kinesiology from Arizona State University. She then expanded her business acumen by completing the CORe Credential of Readiness, a Harvard Business School Online (HBS) program at Harvard Business School.

Outside of her professional pursuits, Marielle leads an active lifestyle. She enjoys running, playing golf, cycling, and spending time with her three children.

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