Sr. Director, Regulatory Affairs Operations

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 our world-class regulatory and government affairs team! Be an important part of our team as we bring Dexcom’s innovative new products to market across the world. Actively contribute within a team of more than 50 regulatory and government professionals and numerous other cross-functional professionals around the world to drive regulatory, governmental, and business deliverables. Be part of this fast-paced global-scope team with an outstanding track record of successes. Be a part of the team that enables more and more people around the world to improve their health as they use our Dexcom Continuous Glucose Monitoring (CGM) products! 

Where you come in: 

• You will have overall responsibility for ensuring cross-functional alignment across Regulatory Affairs strategy leads, Clinical, QA, R&D, Operations and other cross-functional teams to ensure timely and accurate generation of submission-ready documents. Develop and maintain submission timelines, tracking progress and proactively identifying and mitigating potential delays.
• You will have overall responsibility for leading the Advertising and Promotional Materials activities and work processes within the Regulatory & Government Affairs Department, across key Marketing, Medical Affairs, Legal, and Regulatory stakeholders, and to ensure its cross-functional alignment across the organization’s Advertising and Promotional claims and materials workstreams and processes.
• You will play an important strategic role both within the RGA department and in working across functions at Dexcom. Manage the budget for regulatory operations, including technology licenses, vendor services, and team resources.
• You will directly manage and develop a high-performing teams, ensuring goals are clear and aligned, obstacles are overcome, team members are fully engaged and being developed, and the team is resourced to meet both current and future business needs.
• You and your team will drive actions and reporting needed to ensure the success of global regulatory submissions and approvals, as well as other key global regulatory deliverables.
• You will lead all work related to policies, processes, aligning, resourcing, tracking, and training. In addition, you will drive continuous improvement activities in this area, and may support larger continuous improvement work within the organization.
• You will actively work with and contribute as an active member in Corporate Teams and support compliance and other critical functions.

What makes you successful:  

• You have strong written and verbal communication skills. You communicate and collaborate effectively with cross-functional partners to ensure alignment, and timely management of program management and Ad Promo activities.
• You work to continuously improve and change work processes as work needs change, ensuring compliance and efficiency of current and future work process needs
• You can find and implement solutions to sometimes complex challenges.
• You have interest in, or are familiarity with, the healthcare industry. Experience with the medical device or biopharmaceutical industry is highly desired.
• You have a demonstrated interest in diabetes (a huge plus!).
• You are highly flexible and able to shift priorities as needed.
• You are a self-starter with exceptional interpersonal skills.

What you’ll get: (this section should not be modif