Senior Regulatory Affairs (SaMD & AI/Cloud Software) Remote

Dexcom Inc.; San Diego (CA); On-site; USD 91,000 - 152,000; Full time

Job summary

Dexcom Inc. is seeking a Sr Regulatory Affairs Specialist in San Diego to lead regulatory activities for software products, including mobile apps and AI/ML data solutions.

You will collaborate with software, engineering and QA teams to ensure compliance with FDA SaMD guidance, ISO/IEC standards and MDR requirements. You will manage product classification, change management and regulatory submissions (US 510(k) and CE) while coordinating cybersecurity and data privacy considerations.

Qualifications

• Bachelor’s degree required; 5–8 years of related experience.
• Experience with SaMD regulations and FDA guidance.
• Familiarity with ISO/IEC 62304 and MDCG guidance is preferred.
• Ability to author classification memos, change assessments and submissions.

Responsibilities

• Lead regulatory affairs for Dexcom software products, including mobile apps, AI/ML data products and cybersecurity initiatives.
• Classify products and manage changes; prepare and submit regulatory documents (US 510(k), pre-submissions).
• Coordinate CE-MDR activities: change notifications, technical file updates and in-country registrations.
• Collaborate with software, QA, marketing and R&D to ensure compliant development processes.

Skills

Regulatory strategy

Regulatory writing

Cross-functional teamwork

SaMD knowledge

Communication skills

Education

Bachelor’s degree in life sciences or engineering

Tools

Regulatory submissions software

Documentation tools

Job description

Dexcom Inc. is seeking a Sr Regulatory Affairs Specialist in San Diego to lead regulatory activities for software products, including mobile apps and AI/ML data solutions.

You will collaborate with software, engineering and QA teams to ensure compliance with FDA SaMD guidance, ISO/IEC standards and MDR requirements. You will manage product classification, change management and regulatory submissions (US 510(k) and CE) while coordinating cybersecurity and data privacy considerations.