Senior Regulatory Affairs, Software & SaMD; AI/ML
Listed on 2026-10-06
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Education / Teaching
Data Scientist, Cybersecurity
Dexcom Inc. is seeking a Sr. Regulatory Affairs Specialist to lead regulatory affairs for software products, including mobile apps, AI/ML data products, and cloud solutions.
You will collaborate with software, quality, cybersecurity, and R&D to streamline processes and ensure compliance with FDA and international standards. The role covers US 510(k) filings, EU MDR change notifications, and in-country registrations, requiring strong regulatory writing and regulator interaction skills.
We would love to welcome a new Senior Regulatory Affairs, Software & SaMD (AI/ML) to our group in San Diego, CA, United States.
We aim to respond to suitable candidates as soon as possible.
Full responsibilities and requirements are described in the listing above.
Learn more about the Senior Regulatory Affairs, Software & SaMD (AI/ML) role in the description above.
We appreciate your interest in this position.
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