Staff Quality Compliance Specialist

Role Overview

Dexcom's Quality Compliance team leads the company's quality initiatives, ensuring Dexcom maintains good standing with global medical device regulatory bodies. The team develops and implements processes that allow Dexcom to operate in compliance with applicable regulations, guidance documents, and standards across the world.

What You Will Do

Review applicable quality requirements, contribute to Dexcom strategies to achieve and maintain compliance, perform gap analyses on Dexcom's existing procedures and records, and support compliance activities for Dexcom sites with quality obligations.

Why It Might Be a Fit

You will have experience with ISO 13485, MDSAP, and EU MDR quality requirements, and enjoy developing compliant processes and identifying efficient ways of working. You will work well independently and within an international and cross-functional team environment.

Requirements

• Bachelor's degree
• 8-12 years of related experience
• Experience with ISO 13485, MDSAP, and EU MDR quality requirements
• Ability to manage multiple complex documents under aggressive regulatory timelines

Benefits

• 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
• Exciting and innovative, industry-leading organization committed to employees, customers, and communities