Dexcom · 4 hours ago
Sr Regulatory Affairs Specialist
San Diego, California
Full-time
Onsite
Mid, Senior Level
$91K/yr - $152K/yr
5+ years expDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Sr. Regulatory Affairs Specialist will lead regulatory efforts for advertising and promotion as well as software products, ensuring compliance with FDA guidance and international standards while collaborating with cross-functional teams.
DiabetesHealth DiagnosticsMedical DeviceSensor
Responsibilities
You are the RA representative on core functional teams for advertising and promotion and 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 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
You are responsible for advising on and representing RA in the assessment of global cybersecurity and data privacy initiatives, regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions
Qualification
Required
Bachelor's degree with a minimum of 5 years of relevant experience in medical device industry in functions such as software engineering, regulatory affairs, software quality, digital health product management
A minimum of 2 years of regulatory affairs experience required
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 digital health products in a regulated environment, strong understanding or mobile/web development, AI/ML technologies, analytics and working knowledge of agile software development methodologies
You have effective verbal and written communication skills
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