Sr Manager Regulatory Affairs- LATAM

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.

Join a dynamic Regulatory Affairs team that plays a critical role in ensuring compliance and supporting Dexcom’s international growth. We’re passionate about collaboration, problem-solving, and making a positive impact in the fast-paced medical device industry. Our team thrives on innovation, teamwork, and a little fun along the way - we believe great results come from great people working together. Join us and help empower people across the globe to improve their health with Dexcom Continuous Glucose Monitoring (CGM) products.

• You will develop and champion Dexcom’s regulatory strategy in Latin America.
• You will interact directly with regulatory bodies to impact review timelines and support positive regulatory outcomes.
• You will act as the Latin America regulatory subject matter expert and internal point of contact, maintaining alignment with key stakeholders across the company, and ensuring regulatory priorities in the region support the company’s commercial goals.
• You will oversee and direct regulatory activities for new and existing medical devices to ensure compliance with applicable regulatory requirements and company policies.
• You will manage external relationships in Latin America, including consultants, industry organizations, and key opinion leaders. You will represent Dexcom at regional conferences.
• You will apply your proactive and strategic mindset throughout all stages of project planning and implementation, identifying potential challenges and preparing contingency plans as applicable, in order to reduce overall project risk.
• You will guide Dexcom’s regulatory staffing strategy for Latin America: attracting talent, developing new team members, and strengthening Dexcom’s regulatory capability in the region.

• You have an in-depth understanding of medical device regulatory requirements in Latin America.
• You have a proven track record interacting directly with regulatory bodies in the region (ex. ANVISA in Brazil, ANMAT in Argentina, COFEPRIS in Mexico, etc.).
• You have professional fluency in both English and Portuguese. Professional fluency in Spanish is a plus.
• You are able to understand and clearly articulate technical, clinical and regulatory details.
• 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…