Sr. Regulatory Affairs Specialist
$91.4k/y-$152.3k/y
Dexcom18 hours ago
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OnsiteFull-timeSenior
Summary
Dexcom Corporation is seeking a Sr. Regulatory Affairs Specialist to join their team in San Diego, CA. The role involves leading regulatory affairs efforts for Dexcom’s SaMD software products and supporting advertising and promotion.
About the Role
As a Sr. Regulatory Affairs Specialist, you will be responsible for reviewing advertising and promotion materials, supporting product classifications, change assessments, and regulatory submissions for software products including mobile applications and AI/ML enabled data products. You will collaborate with cross-functional teams to ensure compliance with FDA guidance documents and international standards.
About You
Required:
- Bachelor’s degree with a minimum of 5 years of relevant experience in the medical device industry.
- A minimum of 2 years of regulatory affairs experience.
Preferred:
- Experience with SaMD regulations and relevant FDA guidance documents.
- Strong writing skills in regulatory documentation and experience interacting with regulators.
Benefits
- Comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
Dexcom
Empowering People to Take Control of Health Dexcom Corporation (NASDAQ DXCM) has been a pioneer in glucose sensing for more than 25 years. Since 1999, we have developed innovative technologies that transformed how people manage diabetes. Our products are part of people’s daily lives, empowering them to live confidently and feel more in control, free to pursue their dreams. Headquartered in San Diego, California, with operations around the world, Dexcom leads by listening to the needs of users, caregivers, and providers, to simplify and improve glucose management.
San Diego, CA