Operational Compliance Specialist 2
Dexcom, Inc

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:

As an Operational Compliance Specialist 2, you will be responsible for overseeing various aspects of quality and compliance within the organization, with a focus on clinical operations. You will play a critical role in ensuring adherence to regulatory standards, maintaining high-quality standards, and fostering a culture of continuous improvement. You will collaborate cross-functionally with various departments to drive clinical quality initiatives and support the company's objectives.

Where you come in:

• Collaborates with Clinical Affairs team members to build an environment conducive to successful quality focused trial execution.
• Ensures efficient oversight and execution of document management and quality systems control processes.
• Ensures training compliance for Clinical Affairs to quality systems and studies.
• Assists in Clinical Affairs inspections and audits.
• Fosters a collaborative working partnership with other functional areas

What makes you successful:

• Thorough understanding of ICH Guidelines, GCP, and FDA regulations
• Operate with a high degree of ethics
• Meet key deadlines and handle multiple projects and tasks simultaneously
• Write and communicate articulately and concisely
• Work proactively, take initiative and ownership, and assess risk
• 5+ years of clinical experience in the clinical/medical device field
• 2+ years of experience in a clinical quality position requiring oversight of GCP regulations
• Experience with quality management systems and learning management systems
• Familiarity with continuous glucose monitoring devices and diabetes management is a plus.

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:

• 5-15%

Experience and Education Requirements:

• Typically requires a Bachelor's degree and a minimum of 2-5 years of related experience.

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-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 enable individuals with disabilities to perform essential functions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.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 Dexcom Talent Acquisition at talentacquisition@dexcom.com.

View the OFCCP's Pay Transparency Non Discrimination Provision at this link.

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. 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 all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

Salary:
$61,900.00 - $103,100.00

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