Staff Quality Compliance Specialist

Dexcom • Remote California, CA

5d • $100,700 - $167,900 • Remote

About The Position

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. Dexcom’s Quality Compliance team leads company quality initiatives and ensures 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 around the globe – join us and help drive best practices!

Requirements

• Experience with ISO 13485, MDSAP and EU MDR quality requirements.
• Experience includes leading or participating in quality initiatives, such as implementing field actions, implementing quality process improvements, and conducting/supporting audits.
• Enjoy developing compliant processes and identifying efficient ways of working.
• Work well independently, as well as within an international and cross-functional team environment.
• Proficient in problem solving, proactive learning, organization, and have excellent communication skills.
• 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.

Nice To Haves

• Additional familiarity with medical device regulatory frameworks in the UK, Switzerland, the Middle East, Africa, South Korea, and/or Latin America is preferred.

Responsibilities

• Responsible coordinator for Field Action activities, including leading stakeholders to develop strategy, communications, conduct reporting, and complete evidence gathering.
• Support responses to inquiries from global medical device regulatory bodies.
• Review quality requirements in applicable geographies and contribute to Dexcom strategies to achieve and maintain compliance in support of Dexcom’s growth.
• Collaborate on compliance activities for Dexcom sites with quality obligations (ex. Review of Importer/Distributor activities, continuous improvement projects, etc.).
• Support internal audits and external audits.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior