Senior Manager, Regulatory Affairs – LATAM

Job not on LinkedIn

🔥 15 minutes ago

🐊 Florida – Remote

🐊 Florida – Remote

💵 $149k - $248.3k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Dexcom

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

📋 Description

• 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 • Maintain alignment with key stakeholders across the company and ensure regional regulatory priorities support commercial goals • Oversee and direct regulatory activities for new and existing medical devices • 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 a proactive and strategic mindset throughout project planning and implementation • Identify potential challenges and prepare contingency plans to reduce overall project risk • Guide Dexcom’s regulatory staffing strategy for Latin America • Attract talent, develop new team members, and strengthen regulatory capability in the region • Travel 15–25%

🎯 Requirements

• In-depth understanding of medical device regulatory requirements in Latin America • Proven track record interacting directly with regional regulatory bodies, such as ANVISA, ANMAT, and COFEPRIS • Professional fluency in both English and Portuguese • Professional fluency in Spanish is a plus • Ability to understand and clearly articulate technical, clinical, and regulatory details • Experience managing high-performing teams • Enjoyment of mentoring and coaching • Ability to develop and implement new processes and identify efficiencies • Ability to work independently and within an international, cross-functional team environment • Proficiency in problem solving, proactive learning, and organization • Excellent communication skills • Previous experience with CGMs or other diabetes devices is preferred • Bachelor’s degree • 13+ years of industry experience • 5–8 years of previous people management experience • Willingness to travel 15–25%

🏖️ Benefits

• 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 employees, customers, and communities • Home office arrangement • Potential Flex workplace option • Potential hybrid working environment for employees within commuting distance of a Dexcom site