Regulatory Affairs Specialist, Medical Device Software

Dexcom Inc.; San Diego (CA); Hybrid; USD 72,000 - 119,000; Full time

Benefits offered by this job

Full benefits package

Growth opportunities

Career development programs

Tuition reimbursement

Job summary

Dexcom Inc. in San Diego, CA is seeking a Regulatory Affairs professional to support software product development and submissions in the US, EU, and Canada.

You will partner with cross-functional teams to develop regulatory strategies and ensure compliant labeling and promotion for software products. The role requires a Bachelor’s degree and 2–5 years of related experience, with a focus on medical device software and design controls (IEC 62304).

Qualifications

• Bachelor's degree required with 2–5 years of related experience.
• Knowledge of US and international regulatory requirements including design control, labeling, and quality systems.
• Experience with medical device software and lifecycle (IEC 62304) recommended.
• Strong technical writing, editing, and analytical skills.

Responsibilities

• Support developmental activities for Dexcom software products.
• Develop regulatory strategies and prepare submissions in the US, EU, and Canada.
• Collaborate with regional regulatory teams to develop global strategies.
• Review and approve software labeling and documentation.
• Represent Regulatory Affairs on cross-functional software teams.
• Coordinate with submission requirements and analyze documentation.

Skills

Regulatory compliance

Regulatory strategy

Technical writing

Cross-functional collaboration

Problem solving

Regulatory submissions

510(k) submissions

Health Canada submissions

EU MDR

Education

Bachelor's degree

Tools

IEC 62304

Job description

Dexcom Inc. in San Diego, CA is seeking a Regulatory Affairs professional to support software product development and submissions in the US, EU, and Canada.

You will partner with cross-functional teams to develop regulatory strategies and ensure compliant labeling and promotion for software products. The role requires a Bachelor’s degree and 2–5 years of related experience, with a focus on medical device software and design controls (IEC 62304).