Staff Quality Compliance Specialist

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $100.7k - $167.9k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

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Dexcom

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

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.

📋 Description

• Coordinate Field Action activities • Lead stakeholders to develop strategy, communications, conduct reporting, and complete evidence gathering • Support responses to inquiries from global medical device regulatory bodies • Review quality requirements in applicable geographies and contribute to compliance strategies • Collaborate on compliance activities for Dexcom sites with quality obligations, including importer/distributor activity reviews and continuous improvement projects • Support internal and external audits

🎯 Requirements

• Typically requires a Bachelor’s degree • Minimum of 8-12 years of related experience • Experience with ISO 13485, MDSAP and EU MDR quality requirements • Familiarity with medical device regulatory frameworks in the UK, Switzerland, the Middle East, Africa, South Korea, and/or Latin America preferred • Experience leading or participating in quality initiatives, including implementing field actions, implementing quality process improvements, and conducting/supporting audits • Ability to develop compliant processes and identify efficient ways of working • Ability to work independently and within an international and cross-functional team environment • Proficiency in problem solving, proactive learning, and organization • Excellent communication skills • Ability to travel 5-15%

🏖️ 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 • Home office workplace • Flex workplace option may be available for employees within commuting distance of a Dexcom site