Experienced Overseas Registration Engineer specializing in IVD global regulatory compliance. Successfully led CE marking and FDA 510(k) clearance for multiple self-test products. Committed to ensuring full compliance and efficient project approval.
Nanjing Synthgene Medical Technology Co., Ltd.
Led CE registration for HCG, HP, FOB, TP self-test products in compliance with EU IVD regulations; all projects successfully certified in 2023–2025.
Obtained FDA 510(k) clearance for HCG self-test kits (strip/cassette/midstream).
Prepared and submitted registration dossiers for Thailand, Indonesia, including technical files.
Tracked and interpreted regulatory updates for FDA, CE and global markets to adjust compliance strategies.
Nanjing Vazyme Biotech Co., Ltd.
Managed QC/QA for NGS platforms, monitored product performance and drove continuous quality improvement.
Collaborated with R&D and production teams to analyze critical quality issues and conduct root cause analysis.
Established raw material pathogen detection and workshop environmental monitoring protocols.
Led quality standard optimization and process improvement, effectively improving product qualification rate.
Anhui Agricultural University
Agronomy and Seed Industry
Chuzhou University
Food Quality and Safety
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