Manager Regulatory Affairs

The Company 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. Dexcom Regulatory Affairs is a department of more than 50 professionals located either at San Diego HQ or remotely around the globe. Our backgrounds range from biological and physical sciences to engineering, political science to biostatistics, pharmacology to law - just to name a few. With our various backgrounds and talents, we help to navigate and align the ideas and output of most facets of the company to successfully get our products to our end users. Our department includes a growing team in EMEA that focuses on regional regulatory compliance initiatives and helps drive strategy for European, Middle Eastern and African markets. Where you come in: You will manage a diverse team of regulatory specialists, developing a collaborative and mutually supportive working environment across a variety of geographies and backgrounds. You will lead medical device regulatory efforts for initial approval and on-going compliance of Continuous Glucose Monitors (CGMs) placed on the market in Europe, the Middle East, Africa and Latin America, including achieving regulatory approval, completing in-country registrations, and reviewing compliance of promotional materials. You will provide regulatory guidance and support for key Dexcom initiatives, including validation and certification activities for a new manufacturing site. You will use your medical device regulatory experience and perspective to drive strategic decisions. What makes you successful: Typically requires a Bachelor's degree with 8-12 years of industry experience You have 2-5 years of previous management or lead experience Your medical device regulatory experience covers European and/or Middle Eastern geographies. African and/or Latin American experience is a plus. You have experience managing high-performing teams. You enjoy mentoring and coaching. You believe strongly in developing talent and finding opportunities for your team members to grow and excel. You enjoy developing and implementing new processes and identifying efficient ways of working. You work well independently, as well as within an international and cross-functional team environment. You are proficient in problem solving, proactive learning, organization, and have excellent communication skills. Previous experience with CGMs or other diabetes devices is preferred. What you'll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 5-15% To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.