[Hiring] Staff Quality Compliance Specialist @Dexcom

Role Description

You will be the responsible coordinator for Field Action activities, including:

• Leading stakeholders to develop strategy and communications
• Conducting reporting and completing evidence gathering
• Supporting responses to inquiries from global medical device regulatory bodies
• Reviewing quality requirements in applicable geographies
• Collaborating on compliance activities for Dexcom sites with quality obligations
• Supporting internal audits and external audits

Qualifications

• 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 is preferred
• Experience leading or participating in quality initiatives
• Enjoy developing compliant processes and identifying efficient ways of working
• Ability to work well independently and within an international and cross-functional team environment
• Proficient in problem solving, proactive learning, organization, and excellent communication skills

Requirements

• Typically requires a Bachelor’s degree and a minimum of 8-12 years of related experience
• A graduate degree may be desirable with 4 years of related experience
• Travel Required: 5-15%

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

Remote Workplace

• Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km)
• If you reside within commuting distance of a Dexcom site, a hybrid working environment may be available