Senior Operational Compliance Specialist

4 days ago

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $82.9k - $138.1k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Dexcom

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Dexcom is a leading provider of continuous glucose monitoring (CGM) systems, revolutionizing how people manage diabetes and track their glucose levels. Known for their best-in-class glucose biosensing technology, Dexcom offers products like the Dexcom G7 CGM system, which provides real-time glucose monitoring and insights to help individuals become healthier. Founded in 1999, Dexcom has consistently innovated in the field of diabetes management, empowering users to take control of their health with accurate and advanced glucose monitoring solutions. Their products are designed for both adults and children and do not require a prescription.

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

10,000+ employees

Founded 1999

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Supports regulated activities and projects to successfully meet department and corporate goals. • Key contributor in support and collaboration for global (primarily Asia Pacific region) distribution and manufacturing licensing. • Works closely with Quality, Regulatory Affairs, Commercial, Legal, Supply Chain, and Operations to ensure compliance with numerous global registration and licensing requirements. • Work is primarily achieved independently or through project teams, utilizing technical or subject-matter expertise to achieve results. • Emphasizes in-depth technical / subject-matter knowledge, project management and influence skills. • Is expected to communicate laterally and engage others across the organization and have some level of influence on decisions.

🎯 Requirements

• Strong project management skills, with ability to coordinate cross-functional teams. • Must be able to comfortably communicate assertively with project stakeholders regarding timelines and dependencies • Must be able to build and sustain partnerships within the organization and with applicable regulatory bodies and Dexcom’s representatives to such bodies. • Solution-driven, risk/impact-based mentality, with a “get it done, the right way” approach. • Ability to interpret and coordinate responses to requests from regulatory bodies or Dexcom’s representatives to such bodies. • Excellent communication skills with the ability to convey quality, and business information clearly and effectively verbally and through informal and formal documents, reports, and presentations. • Experience in a regulated environment, preferably within medical device, pharma, aerospace, or similar industry.