· Spearheaded the regulatory approval and the first-ever designation of Korea’s Innovative Health Technology for “nProfiler® 1 Stomach Cancer Assay”, the world’s first genetic test for gastric cancer prognosis.
· Successfully obtained regulatory approval for “nProfiler® OlivA G”, an AI-based pathological diagnostic software for gastric cancer.
· Created and operated quality systems required under KGMP and ISO 13485 standards (molecular diagnostic devices and IVD software).
· Conducted numerous clinical performance studies, including large-scale, multicenter clinical trials.
· Obtained institutional certifications and technology certifications, including Innovative Medical Device Company, NET (New Excellent Technology), Inno-Biz, etc.
· Managed global intellectual property rights, technology transfer, and Design History File documentation.
· Possesses hands-on experience in national R&D programs, industry collaborations, investor relations, and IPO preparation.
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