Regulatory Affairs Specialist jobs in United States
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Dexcom · 14 hours ago

Regulatory Affairs Specialist

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), aiming to empower people to take control of health. The Regulatory Affairs Specialist will support regulatory affairs efforts, ensuring compliance with advertising and promotional materials while facilitating review processes across teams.

DiabetesHealth DiagnosticsMedical DeviceSensor
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H1B Sponsor Likelynote

Responsibilities

You will support review of advertising and promotional material in accordance to internal procedures as part of the MLR review process
You act as SME for Dexcom’s products and regulatory requirements for promotional activities
You can provide guidance to material authors and reviewers on regulatory and internal policy requirements
You also help facilitate alignment of global product claims across regional SMEs
You help support process improvement by working with cross functional team to make changes to current process pain points and optimize review efficiency
You will monitor changes with applicable US and international regulations and standards
You provide summaries for these changes to inform compliance needs and best practices for advertising and promotional review
You can create reports & metrics to provide visibility to marketers, reviewers and management on process efficiency
You will perform other duties as assigned

Qualification

Regulatory AffairsMedical Device IndustryAdvertising & Promotional Labeling21 CFR RegulationsEU MDRProject ManagementCommunication SkillsAttention to DetailOrganizational Skills

Required

Experience with regulated medical device industry, and experience in Advertising & Promotional labeling requirements
Excellent writing and verbal communication skills
Strong attention to detail
Highly organized
Experience managing projects within a cross functional environment
Knowledge of 21 CFR regulations, EU MDR
Interest in the medical device industry, diabetes care, business system best practices
Typically requires a Bachelor's degree and a minimum of 2-5 years of related experience

Preferred

Regulatory Affairs experience
Advanced degree may substitute for years of experience

Benefits

A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.

Company

Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.

H1B Sponsorship

Dexcom has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (41)
2023 (67)
2022 (75)
2021 (49)
2020 (36)

Funding

Current Stage
Public Company
Total Funding
$2.16B
Key Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M

Leadership Team

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Jacob Leach
Chief Operating Officer
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Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
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Company data provided by crunchbase