Belinda Smith

About Belinda Smith

I am the Director of Product Strategy & Program Management at RxSight, Inc, where I lead cross-functional initiatives to drive innovation, streamline development processes, and align product vision with business goals in the ophthalmic medical device space. With a strong foundation in both strategic planning and operational execution, I work closely with R&D, marketing, regulatory, and clinical teams to ensure the successful delivery of transformative intraocular lens technology.Graduating from the University of Southern California, I bring a multidisciplinary perspective that blends engineering, business insight, and customer-focused thinking. My career spans over a decade of experience in the medical device industry, where I’ve led global product launches, portfolio optimization efforts, and enterprise-level program execution.My passion lies in building strategies that not only advance medical technology but also improve patient outcomes. I’m energized by solving complex problems, mentoring emerging leaders, and driving meaningful collaboration across teams and stakeholders.

Experience

1. Director Product Strategy

   RxSight, Inc.

   Jul 2024 — Present

   Direct cross-disciplinary medical device projects from concept and feasibility to validation, regulatory submission and approval, commercial launch, and post-market surveillance.Manage the project/program management teams.Foster and inspire strong, cohesive, goal-focused teams by leveraging my proven track record of leading complex cross-disciplinary projects, my passion for healthcare technology, and my delight in mentoring engineers and business leaders.Own a diverse portfolio of 40+ projects, including projects in research and development, manufacturing operations, regulatory affairs, and quality assurance. Build team motivation for projects and ensure effective project prioritization and project execution.Deliver and complete crucial projects by integrating my people, strategic planning, and technical skills, including cross-disciplinary knowledge of regulations, product performance, and quality system requirements.Lead cross-functional project teams composed of R&D, Engineering, Regulatory, Quality, Medical Affairs, Commercial Operations, Manufacturing Operations, and Supply Chain staff.Define product development and regulatory strategies using my direct experience with US and international regulators, along with my wealth of design, development, and manufacturing experiences.Craft successful regulatory narratives and submissions for medical device approval in the US and internationally, including 800+ device changes in the past 12 months.Advise as regulatory strategy subject matter expert for design and manufacturing projects.Create and successfully implement companywide processes for change management and project management, resulting in expedited project completion, reduced staffing needs, and improved team communication.

Education

• University of Southern California

  Master of Business Administration - MBA