Sr Manager Regulatory Affairs- LATAM

Dexcom, Inc.; Florida; Remote; USD 149,000 - 248,000; Full time

Job summary

Dexcom Corporation seeks a Senior Regulatory Affairs leader to own LATAM regulatory strategy, interact with agencies and guide regulatory activities for medical devices across Latin America.

You will manage external relationships, mentor a growing team, and align regulatory priorities with Dexcom’s commercial goals while driving process improvements and regional compliance excellence.

Fluency in English and Portuguese required; Spanish a plus; travel 15-25%.

Qualifications

• Bachelor's degree required; 13+ years in industry preferred.
• Experience leading regulatory teams in medical devices preferred.
• Fluency in English and Portuguese; Spanish a plus.

Responsibilities

• Develop regulatory strategy for Latin America.
• Interact with regulatory bodies to influence review timelines and outcomes.
• Direct regulatory activities for new and existing devices to ensure compliance.
• Manage external relationships with consultants, industry bodies, and key opinion leaders.

Skills

Regulatory strategy

Regulatory affairs

People management

Cross-functional

English fluency

Portuguese fluency

Education

Bachelor's degree

Job description

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.

Meet the team:

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.

Where you come in:

• 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.

What makes you successful:

• 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 implementing new processes as well as identifying efficiencies in current 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: (this section should not be modified)

• 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:

• 15-25%

Experience and Education Requirements:

• Typically requires a Bachelor’s degree with 13+ years of industry experience
• 5-8 years of previous people management experience

Remote Workplace:

Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail].

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [e-mail].

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

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.

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Salary: $149,000.00 - $248,300.00

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