Dexcom · 3 months ago
Sr Manager Regulatory Affairs
San Diego, California
Full-time
Hybrid
Senior Level, Lead/Staff
$142K/yr - $236K/yr
13+ years expDexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), aiming to improve health outcomes for diabetes management and beyond. The Sr. Manager of Regulatory Affairs will lead regulatory efforts for software products, including mobile applications and AI/ML enabled data products, while overseeing a team and ensuring compliance with FDA and international standards.
DiabetesHealth DiagnosticsMedical DeviceSensor
Responsibilities
You will spearhead regulatory strategy and execution for SaMD and SiMD products, features, cloud-based solutions, data connectivity and integration efforts, and other software components within the Dexcom digital health ecosystem. You will also supervise a team of regulatory affairs specialists
You are the RA lead on core functional teams for global software regulatory classification, change management, regulatory submissions including:
US 510(k), pre-submissions, LTF, MDDS change assessment
CE-marked products under EU MDR: change notifications, technical file update, MDSS notifications and in-country registrations
ROW: work with regional regulatory teams to help support interactions with regulatory bodies or in-country representatives for device classification assessments, registration and amendments
You will work with SW development, cybersecurity, architect, quality, product management. Medical/clinical affairs and other cross functional teams to develop and implement streamlined software product development and design control processes to meet regulatory compliance requirements
You will represent RA in assessment of global cybersecurity, data availability and data privacy initiatives. You are responsible for advising on regulatory standards, requirements and guidance from regulatory authorities to meet security process and documentation requirements for global submissions
Qualification
Required
Typically requires a Bachelor's degree with 13+ years of relevant experience in medical device industry in functions such as engineering, regulatory affairs, software quality, digital health product and program management
5-8 years of previous people management experience
A minimum of 5 years of regulatory affairs experience
You have a strong track record interpreting and implementing SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO-14971, ISO-80001, IEC 62304 IEC 82304) to advise on regulatory strategy
You have excellent writing skills in regulatory documentation, including classification memos, change assessment/notifications, technical dossier and submissions. You are experienced in interactions 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 excellent verbal and written communication skills, and success in managing a team
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
2026-01-13
Company data provided by crunchbase