Senior Regulatory Affairs Specialist
Dexcom(2 months ago)
About this role
A Regulatory Affairs position at Dexcom supporting global market access for continuous glucose monitoring (CGM) products. The role is part of a regulatory team focused on ensuring compliance with evolving medical device regulations and supporting product lifecycle activities for software-enabled devices.
Required Skills
- SaMD Regulations
- FDA Guidance
- MDCG Guidance
- ISO Standards
- IEC Standards
- Regulatory Strategy
- Regulatory Submissions
- Technical Dossier
- Classification Memos
- Change Assessment
+8 more
Qualifications
- Bachelor's Degree
About Dexcom
dexcom.comDexcom Continuous Glucose Monitoring is simplifying diabetes management with a small device, accurate real-time glucose readings, and proven results. No fingersticks or scanning.†
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