Uma Gaur

Background

About Uma Gaur

I’m a RAC (US, EU, Canada) certified Regulatory Affairs Leader with 15+ years of experience in global regulatory strategy, compliance, and scientific research—specializing in in-vitro diagnostic (IVD) medical devices. With a Ph.D. in Biotechnology and a deep background in molecular diagnostics, I’ve successfully led Class I–IV IVDs through regulatory approvals across North America, the EU, UK, LATAM, APAC, WHO, and other global markets. I’ve developed and executed regulatory submissions including 510(k), CE marking, ITA, IVDR, MDL, and WHO-EUL. My leadership directly enabled the approval of five COVID-19 diagnostics within two years, supporting the Canadian government’s acquisition of 50 million rapid tests—an effort recognized in national media ([CityNews](https://toronto.citynews.ca/2022/01/06/covid-canada-rapid-antigen-tests-artron/)). Trained in ISO 14971:2019, I apply structured risk management practices across the product lifecycle—conducting hazard identification, benefit-risk analysis, mitigation planning, and regulatory reporting to support compliance and market success. My scientific foundation includes 60+ peer-reviewed publications and over 2,500 citations in the fields of aging, neurodegenerative diseases, cancer, and drug development.([Google & hl=en)) This research experience gives me a unique ability to align technical innovation with global regulatory requirements. In ISO 13485 and MDSAP environments, I’ve led supplier audits, post-market surveillance, internal audits, and global clinical trial coordination. I’ve trained and mentored over 20 new hires on regulatory practices and worked closely with regulatory bodies, CROs, and internal teams to bring compliant, safe, and innovative diagnostics to market. Empathetic, multilingual, and highly collaborative, I thrive in cross-functional environments and bring both strategic vision and operational precision to every project. Let’s connect if you’re involved in:* Regulatory strategy for IVDs or medical devices * Global market access or submission planning * Scientific collaboration in biotech or diagnostics * Building high-performing regulatory teams