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:
As a Regulatory Affairs Support 4, you will play a crucial role within Dexcom's Regulatory Affairs department, collaborating with internal teams and external regulatory bodies such as the FDA, Health Canada, and European notified bodies. Your diverse skill set will be essential in submission publishing and supporting data analytics applications. This role requires adaptability, efficiency, and strong communication skills, working across departments and with external partners as needed.
Where you come in:
You will develop regulatory submissions for publishing, including but not limited to:US submissions (IDEs, 510(k)s, Q-Subs/Pre-Subs, etc.)
EU submissions, filing and amending Technical Files and Documentation
Canada submissions for medical device applications
Collaborate on global strategies for submissions in other markets as required
You will represent Regulatory Affairs on various cross-functional teams.
You will maintain and update the Regulatory Affairs Database (RAD) to track submissions and ensure accuracy.
You will follow established procedures while identifying opportunities to standardize Regulatory Operations processes.
You will perform additional duties as assigned to support the overall function of the Regulatory Affairs team.
What makes you successful:
You have a minimum of 2 years of related experience and a bachelor's degree, or equivalent work experience.
You are skilled in writing, editing, and analyzing complex submissions with minimal supervision.
You will effectively plan and manage the completion of regulatory submission publishing projects.
You have experience working independently or within cross-functional teams.
Your proficiency includes Adobe Acrobat Pro, Microsoft Excel, and Microsoft Word.
Preferred Qualifications:
You have basic knowledge of regulatory deliverables, timelines, and submission best practices.
You understand US, EUMDR, APAC & EMEA regulations and submission processes.
You are familiar with operational initiatives like electronic submissions, project planning, and software applications such as Oracle Cloud PLM and DocShifter.
You bring knowledge of SharePoint and Office 365 to streamline workflow and documentation processes.
Experience and Education:
Typically requires a minimum of 2-4 years of related experience and a Bachelor's Degree.
#LI-Hybrid
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 unsolicitedresumes/applications.