Senior Regulatory Affairs, Software & SaMD (AI/ML)

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

Benefits offered by this job

Benefits program

Career development

Job summary

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.

Qualifications

• Experience with SaMD regulations and FDA guidance documents.
• Experience interacting with regulators.
• Strong understanding of mobile/web development, AI/ML, and analytics.
• Excellent regulatory writing skills.

Responsibilities

• Lead RA efforts for Dexcom's software products.
• US 510(k), pre-submissions, LTF, MDDS change assessment.
• CE-marked products under EU MDR: change notifications, technical file updates and submissions.
• ROW: work with regulatory bodies or in-country representatives for device classification, change assessment, registration and amendments.
• Collaborate with SW development, engineering, quality and cybersecurity to meet regulatory and quality requirements.
• Advise on global cybersecurity and data privacy regulatory standards for submissions.

Skills

SaMD regulations

FDA guidance

MDCG guidance

ISO/IEC 62304

ISO 14971

ISO 80001

Regulatory strategy

Regulatory writing

Regulator interaction

Mobile/Web development understanding

AI/ML technologies

Agile software development

Analytics

Communication skills

Education

Bachelor's degree

Job description

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.