Jobs at InBios International, Inc.

Support regulatory strategy, submissions, and lifecycle management for IVD products. Prepare and review protocols, EUAs, 510(k)s, technical files, design history files, labeling, and risk management. Coordinate with cross-functional teams and regulatory bodies to ensure compliance for lateral flow and real-time PCR assays.

Perform routine GMP manufacturing tasks for diagnostic ELISA kits: prepare buffers/reagents, operate equipment, assemble/label/package components, maintain batch records, and follow safety and quality procedures.

Lead end-to-end IVD development programs for infectious disease and oncology diagnostics, managing government-funded contracts through development, GMP manufacturing, clinical validation, and FDA/CE regulatory submission. Coordinate assay development (immunochemistry and molecular), oversee documentation, timelines, budgets, risk mitigation, CROs, clinical sites, and sponsor communications.