Dhana Nair-Schaef

WORK HISTORY

EDUCATION

ABOUT DHANA NAIR-SCHAEF

I’m an IVD and medical device R&D leader with 20+ years in life sciences and 9+ years developing regulated diagnostic and point-of-care products from early-stage concept through design controls, verification and validation (V&V), regulatory submission, and global commercialization. My work spans assay development, qualitative and quantitative methods, microfluidics, infectious disease diagnostics, oncology biomarkers, and small-molecule screening.I lead end-to-end product development lifecycles, managing cross-functional teams across biology, chemistry, engineering, manufacturing, quality, and operations. I focus on aligning scientific direction with regulatory strategy, product requirements, and target product profiles so teams can move quickly and confidently through phase-gate milestones.I have deep experience with U.S. and international regulatory pathways, including 510(k) submissions, FDA clearance, EUA authorization, CE marking, IVDR, ISO 13485 design controls, ISO 14971 risk management, and audit readiness. I work closely with regulatory affairs, clinical, and quality teams to de-risk programs, maintain compliance, and prepare complete design history files (DHF) and technical documentation.One of the highlights of my career was leading a 13-person team to develop and launch the first EUA-approved OSOM Flu SARS-CoV-2 Combo Test in the U.S. I’ve also led rapid-turnaround programs, including an oral-fluid antibody test that moved from concept to prototype in eight weeks and later received EUA authorization and CE marking. My work often includes technology transfer to manufacturing, scaling new platforms, and creating robust processes that support sustained production.Earlier in my career, I focused on infectious disease drug discovery and small-molecule screening, leading assay development, hit-to-lead activities, and multidisciplinary project work. Across all roles, I contribute as a subject matter expert by developing SOPs, troubleshooting complex technical issues, guiding new technology integration, and supporting customer and field teams. I’ve also partnered with FDA, NIAID, KOLs, OEMs, and CMOs.Teaching and mentoring are important to me. I enjoy helping early-career scientists grow into confident contributors and future leaders.I’m open to Head of R&D, R&D Director, and VP-level opportunities in IVD, POCT, CDx and medical device organizations looking for someone who can unite scientific rigor, product strategy, and cross-functional execution to deliver meaningful diagnostic products.