Dexcom
Senior Regulatory Affairs Specialist
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). We strive to transform diabetes management and empower people worldwide with personalized, actionable health insights. Our ambition extends beyond diabetes to broader consumer health technology, constantly reinventing biosensing experiences to improve global health outcomes.
Role Overview Join our world‑class regulatory team to advance Dexcom’s innovative products. In a fast‑paced environment, you will develop and apply advanced regulatory expertise while collaborating across functions to lead regulatory activities, including software projects and promotional material reviews.
Responsibilities
Represent Regulatory Affairs on core functional teams for post‑market changes 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 updates, submissions, MDSS notifications, and in‑country registrations
ROW: work with regulatory bodies or in‑country representatives on device classification, change assessment, registration, and amendments
Provide direct support to RA team members reviewing and approving marketing claims, labeling, and advertising materials for Dexcom products.
Partner closely with marketing, clinical, medical affairs, and other functions to develop and approve compliant advertising and promotional materials.
Collaborate with software development, engineering, quality, and cybersecurity teams to implement streamlined development processes and documentation that meet regulatory, quality system, and compliance requirements.
Qualifications
Experience in SaMD regulations, FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO‑14971, ISO‑80001, IEC 62304, IEC 82304) to advise on regulatory strategy.
Excellent writing skills in regulatory documentation, including classification memos, change assessments/notifications, technical dossiers, and submissions. Experience interacting with regulators.
Passionate about continuous improvement and adapting to change to ensure compliance for global medical device regulations, design controls, change controls, and risk management.
Effective verbal and written communication skills and ability to collaborate cross‑functionally for alignment and timely review.
Knowledge of advertising and promotional material review for medical devices; experience using Veeva PromoMats is desired.
Benefits
Front‑row seat to life‑changing CGM technology and a supportive community of Dexcom Warriors.
Comprehensive benefits program including health, dental, vision, and retirement plans.
Global growth opportunities and career development through in‑house learning programs and tuition reimbursement.
Innovative, industry‑leading organization committed to employees, customers, and communities.
Travel
0‑5% domestic travel required.
Experience & Education Requirements
Bachelor’s degree and 5–8 years of related experience, typically in regulatory affairs or a related field.
Remote Workplace You will work from a home office. Living within commuting distance of a Dexcom site may allow a hybrid arrangement. Please inquire about the Flex workplace option.
Equal Opportunity Employer Dexcom is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. We provide reasonable accommodations to enable individuals with disabilities to perform essential functions of the job. For accommodation requests or EEO inquiries, contact Dexcom Talent Acquisition.
Salary $91,400.00 – $152,300.00 annually.
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Role Overview Join our world‑class regulatory team to advance Dexcom’s innovative products. In a fast‑paced environment, you will develop and apply advanced regulatory expertise while collaborating across functions to lead regulatory activities, including software projects and promotional material reviews.
Responsibilities
Represent Regulatory Affairs on core functional teams for post‑market changes 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 updates, submissions, MDSS notifications, and in‑country registrations
ROW: work with regulatory bodies or in‑country representatives on device classification, change assessment, registration, and amendments
Provide direct support to RA team members reviewing and approving marketing claims, labeling, and advertising materials for Dexcom products.
Partner closely with marketing, clinical, medical affairs, and other functions to develop and approve compliant advertising and promotional materials.
Collaborate with software development, engineering, quality, and cybersecurity teams to implement streamlined development processes and documentation that meet regulatory, quality system, and compliance requirements.
Qualifications
Experience in SaMD regulations, FDA guidance documents, MDCG guidance documents, ISO and IEC standards (ISO‑14971, ISO‑80001, IEC 62304, IEC 82304) to advise on regulatory strategy.
Excellent writing skills in regulatory documentation, including classification memos, change assessments/notifications, technical dossiers, and submissions. Experience interacting with regulators.
Passionate about continuous improvement and adapting to change to ensure compliance for global medical device regulations, design controls, change controls, and risk management.
Effective verbal and written communication skills and ability to collaborate cross‑functionally for alignment and timely review.
Knowledge of advertising and promotional material review for medical devices; experience using Veeva PromoMats is desired.
Benefits
Front‑row seat to life‑changing CGM technology and a supportive community of Dexcom Warriors.
Comprehensive benefits program including health, dental, vision, and retirement plans.
Global growth opportunities and career development through in‑house learning programs and tuition reimbursement.
Innovative, industry‑leading organization committed to employees, customers, and communities.
Travel
0‑5% domestic travel required.
Experience & Education Requirements
Bachelor’s degree and 5–8 years of related experience, typically in regulatory affairs or a related field.
Remote Workplace You will work from a home office. Living within commuting distance of a Dexcom site may allow a hybrid arrangement. Please inquire about the Flex workplace option.
Equal Opportunity Employer Dexcom is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. We provide reasonable accommodations to enable individuals with disabilities to perform essential functions of the job. For accommodation requests or EEO inquiries, contact Dexcom Talent Acquisition.
Salary $91,400.00 – $152,300.00 annually.
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