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Job Details

Senior Regulatory Affairs Specialist

Location
San Diego, CA

Date Last Verified
Jun 14,2018

Posted on
Jun 09,2018

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Profile

Summary:



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.



Desired Qualities:



  • High energy level; positive attitude; works well under stress; strong communicator


  • Focus on continuous improvement; familiar with balancing Quality and efficiency


  • Comfortable with ambiguity and change


The following areas of focus may be available:



US products



  • Interact with FDA, especially in writing 510(k)s, PMA supplements, annual reports, and IDEs


  • Emphasis on writing and organizing short-term and long-term projects


  • Ideal candidate has experience in Regulatory Affairs and/or a background in science or an aptitude for scientific disciplines, such as biochemistry, electrical engineering, software engineering, and wireless technology


International products



  • Interact with international regulatory agencies and notified bodies


  • Emphasis on juggling multiple regions with both short-term and long-term projects


  • Ideal candidate has experience in Regulatory Affairs and/or a background in science or an aptitude for scientific disciplines, such as electrical engineering or biochemistry


Software projects



  • Interact with FDA in pre-submissions and 510(k) submissions


  • Interpret and influence new and evolving regulations on software applications and data systems


  • Emphasis on overlapping short-term and long-term software projects


  • Ideal candidate has experience in Regulatory Affairs and/or a background or aptitude for software engineering


Advanced research



  • Interact with FDA in pre-submissions and writing IDEs


  • Emphasis on future products that require clinical studies


  • Ideal candidate has experience in Regulatory Affairs and/or a background in science or an aptitude for scientific disciplines, such as biochemistry or electrical engineering


Open positions may be adapted based on the candidates background and experience, and each position may provide opportunities to participate in projects outside of its initial scope.

Company info

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