Staff Quality Compliance Specialist

Dexcom • San Diego, CA

4d • Remote

About The Position

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: You will work with cross-functional teams with the goal of ensuring and maintaining product safety and efficacy. The position uses technical knowledge and experience to ensure strategies for product and processes meet regulatory and business objectives. This role is responsible for leading the development, coordination, and submission of written correspondence to the U.S. Food and Drug Administration (FDA), including responses to FDA Warning Letters, 483 observations, and related regulatory communications. This role serves as the primary technical writer and editor for documents while also acting as a coach and reviewer to cross-functional stakeholders across Quality, Regulatory Affairs, Engineering, Operations, Manufacturing, and Clinical.

Requirements

• Exceptional technical writing and editing skills
• Strong regulatory judgment and attention to detail
• Ability to distill complex information into clear, regulator-ready language
• Executive-level written communication
• Influencing and coaching skills in a matrixed organization
• High level of professionalism, discretion, and accountability
• Ability to manage multiple complex documents under aggressive regulatory timelines
• 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

Responsibilities

• Quality Management Systems: Identify applicable processes for new standards and regulations.
• Ensure departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards.
• Aid in designing and documenting new and revised quality systems for product realization compliance with applicable regulations and standards.
• Ensure QMS processes, procedures, and quality documentation to maintain a state of audit readiness.
• Escalate events that may contribute negatively to medical devices safety or efficacy.
• Address and remediate events that may contribute negatively to QMS processes or effectiveness.
• Apply critical analytical thinking in the investigations and nonconformance systems specifically during root cause analysis, risk assessment evaluation, and corrective and preventive actions determination to guarantee that (potential and actual) nonconformances are properly addressed.
• Support other functions in resolving quality systems issues and concerns.
• Audit: Support internal, and third-party audits, regulatory inspection preparation and execution.
• Assist in closing audit findings by providing quality guidance for investigations, and implementation of resulting corrections, and/or corrective actions/preventative actions.
• FDA Correspondence and Technical Writing: Serve as the primary author for FDA Warning Letter responses, follow-up correspondence, commitments, and status updates.
• Draft, edit, and finalize complex regulatory documents, ensuring: Clarity, conciseness, and professional regulatory tone Alignment with FDA regulations (e.g., 21 CFR Part 820), guidance, and enforcement expectations Consistency across commitments, CAPAs, remediation plans, and supporting evidence Translate complex technical, quality, and operational information into clear, regulator-ready narratives.
• Ensure responses are complete, defensible, and supported by objective evidence and timelines.
• Coaching and Writing Review: Act as a writing coach and editor for functional SMEs contributing to FDA responses and related regulatory documents.
• Review and edit drafts prepared by others to improve: Structure and logic Regulatory clarity Technical accuracy Alignment with FDA expectations and enforcement context Provide constructive feedback and guidance to elevate the organization’s overall regulatory writing capability.

Benefits

• 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.

What This Job Offers

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