Ravi Vijayendran Email & Phone Number

I am a seasoned cross-functional leader with over 10 years of experience developing and supporting in vitro diagnostic medical device products from development, quality, regulatory, and manufacturing perspectives. I have played key roles in product development, manufacturing transfer, developing / sustaining quality systems, and regulatory submissions. My efforts have led to the successful development and commercialization of more than 10 products.My career journey began in R&D, developing immunodiagnostic tests and quality control products for the point-of-care and clinical laboratory. Advancing through various R&D and operational roles, I've successfully contributed to products throughout their lifecycle. In the process, I have gained extensive expertise and skill sets across numerous areas critical to product development, commercialization, and medical device products. A few highlights include:Design controlsRisk managementDeveloping / sustaining Quality System ProcessesAssay developmentProcess developmentAnalytical and clinical performance testingProduct flex studiesRoot cause investigationsExternal manufacturing and strategic sourcingSupporting regulatory submissionsI am eager to apply my skill set and expertise to continue advancing healthcare products. Please reach out to learn more about my professional journey and how I can bring value to your team.

Listed skills include Biotechnology, Product Development, Medical Devices, Fda, and 5 others.