Dexcom · 2 months ago
Senior Regulatory Affairs Specialist
San Diego, California
Full-time
Hybrid
Senior Level
$91K/yr - $152K/yr
5+ years expDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), aiming to improve human health. The Senior Regulatory Affairs Specialist will play a key role in leading regulatory activities for innovative products, collaborating with various teams to ensure compliance and successful market entry.
DiabetesHealth DiagnosticsMedical DeviceSensor
Responsibilities
You will represent RA on core functional teams for post-market changes or global software regulatory classification, change management, and regulatory submissions including:
US 510(k), pre-submissions, LTF, MDDS change assessment
CE-marked products under EU MDR: change notifications, technical file update and submissions, MDSS notifications and in-country registrations
ROW: work with regulatory bodies or in-country representatives for device classification, change assessment, registration and amendments
You will provide direct support to RA team members reviewing and approving marketing claims, labeling, and advertising and promotional materials for life altering Dexcom products
You will closely partner with marketing, clinical, medical affairs, and other functions as you develop and approve impactful compliant advertising and promotional materials
You may work closely with SW development, engineering, architect, quality and cybersecurity teams to develop and implement streamlined software development processes and documentation to meet regulatory, quality system and compliance requirements
Qualification
Required
Typically requires a Bachelor's degree and a minimum of 5 – 8 years of related experience
Your experience in SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC 82304) to effectively advise on regulatory strategy
You have excellent writing skills in regulatory documentation, including classification memos, change assessment/notifications, technical dossier and submissions
You have experience interacting with regulators
You are passionate about continuous improvement and adapting to change to ensure compliance, especially for global medical device regulations, design controls, change controls and risk management
You communicate and collaborate effectively with cross-functional partners to ensure alignment and timely review of quality documentation
You have current knowledge and experience in the review of Advertising and Promotional materials for medical devices
You have effective verbal and written communication skills
Preferred
Experience using Veeva PromoMats is desired
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
Dexcom develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management.
10001+ employees
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 CompanyTotal Funding
$2.16BKey Investors
RWI Group
2023-05-02Post Ipo Debt· $1B
2020-05-12Post Ipo Debt
2018-11-01Post Ipo Equity· $750M
Leadership Team
Jacob Leach
Chief Operating Officer
Matt Dolan
Executive Vice President, Strategy, Corporate Development & Dexcom Labs
Recent News
2026-01-16
Medical Device Network
2026-01-15
Company data provided by crunchbase