Sr Manager Regulatory Affairs- LATAM

DexcomRemote Florida, FL
$149,000 - $248,300Remote

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. 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.

Requirements

  • In-depth understanding of medical device regulatory requirements in Latin America.
  • Proven track record interacting directly with regulatory bodies in the region (ex. ANVISA in Brazil, ANMAT in Argentina, COFEPRIS in Mexico, etc.).
  • Professional fluency in both English and Portuguese.
  • Able to understand and clearly articulate technical, clinical and regulatory details.
  • Experience managing high-performing teams.
  • Enjoy mentoring and coaching.
  • Believe strongly in developing talent and finding opportunities for your team members to grow and excel.
  • Enjoy developing and implementing new processes as well as identifying efficiencies in current ways of working.
  • Work well independently, as well as within an international and cross-functional team environment.
  • Proficient in problem solving, proactive learning, organization, and have excellent communication skills.
  • Typically requires a Bachelor’s degree with 13+ years of industry experience
  • 5-8 years of previous people management experience

Nice To Haves

  • Professional fluency in Spanish is a plus.
  • Previous experience with CGMs or other diabetes devices is preferred.

Responsibilities

  • Develop and champion Dexcom’s regulatory strategy in Latin America.
  • Interact directly with regulatory bodies to impact review timelines and support positive regulatory outcomes.
  • 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.
  • Oversee and direct regulatory activities for new and existing medical devices to ensure compliance with applicable regulatory requirements and company policies.
  • Manage external relationships in Latin America, including consultants, industry organizations, and key opinion leaders.
  • Represent Dexcom at regional conferences.
  • 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.
  • Guide Dexcom’s regulatory staffing strategy for Latin America: attracting talent, developing new team members, and strengthening Dexcom’s regulatory capability in the region.

Benefits

  • 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.
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