Operational Compliance Specialist

3 days ago

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Dexcom

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Continuous Glucose Monitoring • Medical Devices • Diabetes • Decision Support • Data

10,000+ employees

Founded 1999

⚕️ Healthcare Insurance

🧬 Biotechnology

Description

• Oversee quality and compliance in clinical operations. • Ensure adherence to regulatory standards. • Maintain high-quality standards and foster continuous improvement. • Collaborate with various departments for clinical quality initiatives.

Requirements

• 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.

Benefits

• 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.