Senior Manager, Regulatory Affairs – LATAM

This is a fully remote position, open to applicants in Florida.

📋 Description

• Develop and promote Dexcom’s regulatory strategy for Latin America.

• Engage directly with regulatory agencies to influence review timelines and foster positive regulatory outcomes.

• Serve as the regulatory subject matter expert for Latin America and the internal contact point.

• Ensure alignment with essential stakeholders throughout the company, making sure that regional regulatory priorities align with commercial objectives.

• Supervise and manage regulatory activities for both new and existing medical devices.

• Guarantee compliance with relevant regulatory standards and company policies.

• Manage external relationships in Latin America, including consultants, industry organizations, and key opinion leaders.

• Represent Dexcom at regional conferences.

• Maintain a proactive and strategic approach during project planning and execution.

• Identify potential obstacles and develop contingency plans to mitigate overall project risks.

• Direct the regulatory staffing strategy for Latin America.

• Attract talent, nurture new team members, and enhance regulatory capabilities in the region.

• Travel 15–25%.

⛳️ Requirements

• Thorough understanding of medical device regulatory requirements in Latin America.

• Demonstrated experience in direct interaction with regional regulatory bodies, such as ANVISA, ANMAT, and COFEPRIS.

• Professional proficiency in both English and Portuguese.

• Professional fluency in Spanish is an advantage.

• Ability to comprehend and clearly convey technical, clinical, and regulatory information.

• Experience in leading high-performing teams.

• Passion for mentoring and coaching others.

• Capacity to develop and execute new processes while identifying efficiencies.

• Ability to work autonomously as well as part of an international, cross-functional team.

• Strong problem-solving skills, proactive learning ability, and organizational capabilities.

• Exceptional communication skills.

• Previous experience with continuous glucose monitors (CGMs) or other diabetes devices is preferred.

• Bachelor’s degree required.

• Over 13 years of industry experience.

• 5–8 years of prior experience in people management.

• Willingness to travel 15–25%.

🏝️ Benefits

• A comprehensive benefits package.

• Opportunities for growth on a global scale.

• Access to career development through internal learning programs and/or qualified tuition reimbursement.

• An exciting and innovative organization that is industry-leading and committed to its employees, customers, and communities.

• Home office arrangement.

• Potential for a flexible workplace option.

• Possible hybrid working environment for employees who live within commuting distance of a Dexcom site.