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: 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.
Salary:
$149,000.00 - $248,300.00
#DexcomUS
