San Jose, California, United States
BioMerieux is a global leader in in-vitro diagnostics, specializing in infectious disease testing and antimicrobial resistance solutions. As a Senior Scientist and Product Manager, I'm responsible for leading the transition of an acquired startup’s R&D operations into BioMerieux’s corporate structure while ensuring regulatory compliance, product development, product management, and market launch success.
• Product Launch & Cross-Functional Leadership – Directed the US launch of VITEK REVEAL, within 237 days, managing 36 team members across 43 initiatives in R&D, manufacturing, industrialization, quality, and regulatory.
• Regulatory Affairs & Market Readiness – Led the successful IVDR submission and conformity assessment request for an in-vitro diagnostic device in Europe, collaborating to author the Design History Summary for compliance.
• Strategic Integration & FDA Compliance – Spearheaded the post-acquisition integration of a startup into our ecosystem, overseeing 510(k) FDA submissions, regulatory documentation, and R&D process standardization.
• AI-Driven Product Management – Acted as Product Manager for 2 new R&D products (hardware and software), driving AI integration into diagnostic tools to enhance clinical decision-making and operational efficiency.