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Dexcom Regulatory Affairs seeks individuals who have an eye for detail, strong writing and organizational skills, and the ability to adapt to change. The Senior Specialist is preferred to have a minimum of three years in Regulatory Affairs, with five years in a regulated medical device company.
Experience or demonstrated aptitude in scientific disciplines, such as biochemistry, electrical engineering, software engineering, wireless technology, and diabetes research experience may substitute for years of experience in Regulatory Affairs.
A role in Regulatory Affairs provides the opportunity to interact with regulatory agencies, like FDA, to help gain pre-market clearance or approval for new medical devices and changes to existing devices. Dexcom has been involved in cutting-edge submissions, including a De Novo to create a new category for interoperable continuous glucose monitoring systems, PMA approval for a direct-to-users mobile app and a positive advisory committee panel vote for an indication change to allow the first continuous glucose monitoring system designed to replace fingerstick blood glucose testing for diabetes treatment decisions.
A Regulatory Affairs Specialist will participate in the Dexcom review and approval process, gain insight into current FDA and international agency thinking, and work strategically with product development teams to assemble successful submission packages for those agencies. Additionally, Regulatory Affairs personnel review outward facing promotional marketing and training material to ensure a consistent and compliant message to end users. Regulatory Affairs personnel work closely with Marketing, R&D, Quality, Operations, and Clinical departments.
Travel to other Dexcom locations and/or to FDA may be required periodically. If a position specifically supports a non-San Diego Dexcom location, more regular travel will be required.