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
Dexcom's Quality Compliance team leads the company's quality initiatives, ensuring Dexcom maintains good standing with global medical device regulatory bodies. We develop and implement processes that allow us to operate in compliance with applicable regulations, guidance documents and standards across the world. Our team balances rigor and pragmatism – we are passionate about collaborating as a team to implement ways of working that are both efficient and compliant. We are expanding our Quality Compliance team to support Dexcom's growth across EMEA and LATAM – join us and help drive best practices in our region.
Where You Come In
* You will identify applicable quality requirements in EMEA and LATAM geographies and drive Dexcom strategy to achieve and maintain compliance.
* You will perform gap analyses on Dexcom's existing procedures and records. You will develop and implement updates and improvements, as required.
* You will lead compliance activities for Dexcom sites with quality obligations (ex. EU Importer/Distributor activities, EUDAMED registrations, etc.).
* You will collaborate on Field Action activities, if applicable, including strategy, communications, reporting and evidence gathering.
* You will compose or collaborate on the composition of communications with regulatory bodies.
* You will drive audit strategy. You will support internal and external audits.
What Makes You Successful
* You have a strong understanding of ISO 13485, MDSAP and EU MDR quality requirements. Additional familiarity with medical device regulatory frameworks in the UK, Switzerland, the Middle East, Africa and/or Latin America is preferred.
* Your experience includes direct involvement in critical quality initiatives, such as driving field action strategy, communicating with regulatory bodies, and supporting audits.
* You enjoy developing compliant processes and identifying efficient 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.
What You'll 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
* 5-15%
Experience And Education Requirements
* Typically requires a Bachelor's degree and a minimum of 8 – 12 years of related experience.
* At this level a graduate degree may be desirable with 4 years of related experience
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.