Sr Manager Regulatory Affairs

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 were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensing-technology experiences. Though weve 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 Dexcoms international growth. Were 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 Dexcoms regulatory strategy in the Asia-Pacific region.
• You will interact directly with regulatory bodies to impact review timelines and support positive regulatory outcomes.
• You will act as the Asia-Pacific 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 companys 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 the Asia-Pacific region including consultants industry organizations and key opinion leaders. You will represent Dexcom at regional conferences.
• You will apply your proactive and strategic mindset throughout project planning and implementation identifying potential challenges and preparing contingency plans as applicable in order to reduce overall project risk.
• You will guide Dexcoms regulatory staffing strategy for the Asia-Pacific region: attracting talent developing new team members and strengthening Dexcoms regulatory capability in the region.

What makes you successful:

• You have an in-depth understanding of medical device regulatory requirements across the Asia-Pacific region.
• You have a proven track record interacting directly with regulatory bodies in the region (ex. MFDS in South Korea PMDA in Japan CDSCO in India etc.).
• You have professional fluency in English and at least one regional language (ex. Korean Japanese etc.). Professional fluency in additional regional languages 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 youll get:

• 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 Bachelors degree with13 years of industry experience
• 5-8 years of previous people managementexperience

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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At Dexcom we are committed to providing a fair and inclusive recruitment process and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary please be assured this is not intentional.

Should a reasonable accommodation be necessary to aid a disability requests should be sent to Dexcom Talent Acquisition at .