Dexcom · 6 hours ago
Staff Quality Compliance Specialist
San Diego, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$101K/yr - $168K/yr
8+ years expDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Staff Quality Compliance Specialist role focuses on ensuring product safety and efficacy through quality management systems, regulatory correspondence, and technical writing, while collaborating with cross-functional teams.
DiabetesHealth DiagnosticsMedical DeviceSensor
Responsibilities
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
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
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
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
Qualification
Required
Typically requires a Bachelor's degree and a minimum of 8-12 years of related experience
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
Preferred
A graduate degree may be desirable with 4 years of related experience
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.
Company
Dexcom
Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.
10001+ employees
H1B Sponsorship
Dexcom has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (41)
2023 (67)
2022 (75)
2021 (49)
2020 (36)
Funding
Current Stage
Public CompanyTotal Funding
$2.16BKey Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M
Leadership Team
Jacob Leach
President and Chief Executive Officer
Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
Recent News
2026-01-16
Medical Device Network
2026-01-15
Company data provided by crunchbase