41 applicants

Company

Dexcom · 4 hours ago

Operational Compliance Specialist 2

Remote - United States

Full-time

Remote

Mid, Senior Level

$62K/yr - $103K/yr

5+ years exp

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DiabetesHealth Care

H1B Sponsor Likely

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Responsibilities

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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

ICH GuidelinesGCPFDA regulationsClinical experienceClinical quality positionQuality management systemsLearning management systemsContinuous glucose monitoringDiabetes managementRisk assessment

Required

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

Typically requires a Bachelor’s degree and a minimum of 2-5 years of related experience

Preferred

Familiarity with continuous glucose monitoring devices and diabetes management is a plus.

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

Glassdoor

3.9

Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.

Founded in 1999

San Diego, California, USA

10001+ employees

http://www.dexcom.com

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

2023 (52)

2022 (55)

2021 (62)

2020 (48)