As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation NYSE: WAT, by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purposeBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

Job DescriptionThe Regulatory Affairs Specialist Innovation is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development NPD teams for in vitro diagnostic IVD products. This position will be responsible for preparing FDA submissions, including, but not limited to: Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510k submissions, and CLIA Waiver applications, a
