Staff Quality Compliance Specialist

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.

Where you come in:

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.

What makes you successful:

• 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

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:

• 0-5%