Regulatory Affairs Scientist

Dexcom • San Diego, CA

4d • Remote

About The Position

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. The Regulatory Scientist will work within Regulatory Affairs, Government Affairs and Global Advocacy and collaborate with cross-functional teams to support efforts for Dexcom’s digital health, software-enabled products, Ad/Promo activities, and advocacy and policy analysis efforts. This role will focus on: leveraging data analytics to inform regulatory strategy and support global advertising and promotional efforts. leveraging clinical study data, product performance data, and data from published studies to help inform regulatory decisions and identify trends in the field. actively monitoring and reporting on the competitive landscape, including regulatory milestones and new data sets, and identify areas of opportunity or risk. identifying and communicating emerging trends and priorities among regulators and identifying areas of opportunity or risk. leading discussions about new technologies, helping situate them in the context of regulatory submissions. developing engaging narratives around technical information, anticipating and clarifying common points of confusion. adapting content based on audience feedback and communicating effectively to wide varieties of audiences. establishing and nurturing cross-functional relationships to strengthen evidence generation strategy to support regulatory submissions. generating strong arguments and anticipating counter-arguments supported by data with logical, effective organization, and refined language and style. You develop dashboards and visualizations to communicate metrics and trends across geographies and products. You work closely with medical affairs, legal, and commercial teams to understand workflows and timelines. You contribute to the development and revision of procedures related to data analysis and regulatory documentation. You monitor evolving policy and advocacy landscape to identify areas of opportunity and growth You lead discussions about new technologies, emerging trends, and analyze data sets to inform business decisions. You perform other duties as assigned.

Requirements

• experience with medical device development and regulatory processes, especially for software as a medical device (SaMD)
• strong analytical skills and proficiency in tools such as visualization platforms like Tableau or Power BI
• familiar with regulatory data sources and standards (e.g., ISO 14971, IEC 62304, FDA guidance on RWE)
• excellent communication skills and can translate complex data into actionable regulatory insights
• passionate about digital health, AI/ML technologies, evolving digital health policy landscape and agile software development
• Typically requires a Bachelor’s degree and a minimum of 2-5 years of related experience

Responsibilities

• develop dashboards and visualizations to communicate metrics and trends across geographies and products
• work closely with medical affairs, legal, and commercial teams to understand workflows and timelines
• contribute to the development and revision of procedures related to data analysis and regulatory documentation
• monitor evolving policy and advocacy landscape to identify areas of opportunity and growth
• lead discussions about new technologies, emerging trends, and analyze data sets to inform business decisions
• perform other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees