Senior Manager Regulatory Affairs

The Senior Manager, Regulatory Affairs will be responsible for providing regulatory expertise and strategic direction for product development and commercialization activities. This role will work cross-functionally with R&D, Quality, Marketing, and other stakeholders to ensure regulatory compliance and timely submissions of applications for regulatory approval. The successful candidate will have a proven track record of successfully navigating complex regulatory environments and managing regulatory submissions for novel medical devices.

Dexcom specializes in developing and marketing continuous glucose monitoring (CGM) systems for diabetes management. Its core product, the Dexcom G6 CGM System, provides real-time glucose readings to patients, allowing them to manage their condition more effectively. Dexcom serves individuals with diabetes, healthcare providers, and caregivers. Its business model focuses on selling CGM devices and related software applications, such as Dexcom CLARITY, which offers data analytics and insights. Revenue comes from device sales and subscription-based services for data management.