Staff Quality Compliance Specialist

The Company reputed company Corporation (reputed company DXCM) is a pioneer and global leader in reputed company glucose monitoring (CGM). reputed company began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive reputed company outcomes. Here we are 25 years reputed company, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to reputed company people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue reputed company'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 reputed company, 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 reputed company 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 reputed company. 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company regulatory documents.
• Review and edit drafts reputed company by others to improve:
• Structure and logic
• Regulatory clarity
• Technical accuracy
• Alignment with FDA expectations and enforcement context
• Provide constructive feedback and guidance to reputed company 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 reputed company 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 reputed company documents under aggressive regulatory timelines

What you’ll get:

• A reputed company row seat to life changing CGM technology. Learn about our reputed company #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%

Experience and Education Requirements: Typically requires a Bachelor’s degree and a minimum of 8-12 years of reputed company experience.

• At this level a graduate degree may be desirable with 4 years of reputed company experience

reputed company Workplace: Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live reputed company commuting distance of your assigned reputed company site (typically 75 miles/120km). Please note: The information contained herein is not intended to be an reputed company-inclusive list of the duties and responsibilities of the job, nor are they intended to be an reputed company-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company essential functions. An Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national reputed company, or protected veteran status and will not be discriminated against on the basis of disability. reputed company’s AAP may be viewed upon request by contacting reputed company at talentacquisition@reputed company.com. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact reputed company reputed company at talentacquisition@reputed company.com. Meritain, an reputed company Company, creates and publishes the Machine-Readable Files on behalf of reputed company. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true To reputed company Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at reputed company. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. reputed company does not accept unsolicited resumes or applications from agencies. Please do not reputed company resumes to the reputed company team, reputed company employees or any other company location. reputed company is not responsible for any fees reputed company to unsolicited resumes/applications. Salary: $100,700.00 - $167,900.00 Apply tot his job Apply To this Job