Staff Quality Compliance Specialist

DexCom • San Diego, CA

1d • Remote

About The Position

Dexcom Corporation (NASDAQ DXCM) is a global leader in continuous glucose monitoring (CGM) technology, aiming to improve human health by empowering people to take control of their health. The Quality Compliance team is responsible for ensuring Dexcom maintains good standing with global medical device regulatory bodies by developing and implementing processes that comply with applicable regulations, guidance documents, and standards worldwide. This role involves supporting the evolution of Dexcom’s Quality Management System.

Requirements

• Experience with ISO 13485, MDSAP, and EU MDR quality requirements.
• Experience includes participation in quality initiatives, such as implementing new processes and supporting audits.
• Ability to manage multiple complex documents under aggressive regulatory timelines.
• Proficient in problem solving, proactive learning, organization, and excellent communication skills.
• Ability to work independently, as well as within an international and cross-functional team environment.

Nice To Haves

• Additional familiarity with medical device regulatory frameworks in the UK, Switzerland, the Middle East, Africa and/or Latin America is preferred.
• Enjoy developing compliant processes and identifying efficient ways of working.

Responsibilities

• Review applicable quality requirements and contribute to Dexcom strategies to achieve and maintain compliance.
• Perform gap analyses on Dexcom’s existing procedures and records.
• Participate in the development and implementation of updates and improvements, as required.
• Support compliance activities for Dexcom sites with quality obligations (e.g., EU Importer/Distributor activities, EUDAMED registrations).
• Translate complex technical, quality, and operational information into clear, regulator-ready narratives.
• Support other functions in resolving quality systems issues and concerns.
• Support internal 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