Sr Manager Regulatory Affairs- LATAM
Indexed description
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.
- 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.
- 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.
- 15-25%
- Typically requires a Bachelor’s degree with 13+ years of industry experience
- 5-8 years of previous people management experience
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 [email protected].
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 [email protected].
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.
AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.
Salary
$149,000.00 - $248,300.00
#DexcomUS
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