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Regulatory Affairs Specialist at Dexcom - ApplyBlast

Regulatory Affairs Specialist

Dexcom

5 months ago

3.6 on Glassdoor

Vilnius, Lithuania

Hybrid

Full Time

Senior

0 applicants

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About this role

A Regulatory Affairs professional at Dexcom is responsible for preparing and submitting regulatory documentation for international product marketing authorizations, reviewing post-approval changes, and collaborating with cross-functional teams to ensure compliance and support the company's growth in the medical device industry.

Responsibilities

Prepare and submit regulatory documentation for international product marketing authorizations
Review and assess post-approval changes
Prepare, review, and submit amendments, supplements, and variations to product marketing applications
Partner with Marketing, Medical, and Legal teams for regulatory strategy and compliance input
Maintain internal regulatory documentation files and systems

Skills

Qualifications

Bachelor's DegreeRelevant Experience

About Dexcom

dexcom.com

Headquarters

San Diego, California, United States

Company Size

10001+ employees

Founded

1999

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Dexcom Continuous Glucose Monitoring is simplifying diabetes management with a small device, accurate real-time glucose readings, and proven results. No fingersticks or scanning.†