Tien Lai is the Senior Director, Quality & Regulatory Compliance at BrightInsight, where she owns the company’s Quality and Regulatory strategy and execution, including BrightInsight’s Quality Management System. She is responsible for ensuring that BrightInsight’s processes, platform, and products conform to customer specifications and applicable global standards, regulations, and guidance, and for setting the roadmap for regulatory compliance and submissions with the FDA and international authorities.
With more than a decade of experience at the intersection of medical device, clinical research, and SaaS compliance, Tien specializes in designing and scaling Quality and Regulatory governance systems for regulated product and digital platform organizations. Her work translates complex regulatory requirements into operating models that support product growth, platform scalability, and inspection resilience. She has built 21 CFR and ISO aligned Quality Management Systems, redesigned enterprise risk architecture, and embedded Part 11 and Annex 11 controls directly into digital platforms, partnering closely with Product, Engineering, Clinical, and Commercial leadership to ensure compliance strengthens market expansion rather than slows it.
Before joining BrightInsight, Tien served as Director of Compliance at Prelude, a private eClinical SaaS platform supporting regulated Life Sciences sponsors, where she established and scaled the enterprise Quality Management System, embedded 21 CFR Part 11 and Annex 11 control logic directly into platform workflows, and built AI-enabled compliance automation to streamline regulatory intelligence, audit response, and client due diligence. Prior to Prelude, she led clinical compliance at Edwards Lifesciences, overseeing global compliance across Transcatheter Heart Valve studies governed by FDA, ISO 14155, and ICH E6, while redesigning risk methodology and strengthening clinical governance. Earlier in her career, Tien held regulatory affairs and quality engineering roles of increasing responsibility at Natera and Smith & Nephew, developing expertise across ISO 13485, 21 CFR 820, EU MDR, and EU IVDR frameworks.
Tien holds a Master of Business Administration in Organizational Management from Eastern University College of Business and Leadership and a Bachelor of Science in Biology from George Mason University. She is a Certified Clinical Research Professional (CCRP) and a Certified Lean Six Sigma Black Belt (CLSSBB), and is an active member of the Society of Quality Assurance and the Society of Clinical Research Associates.