Regulatory Affairs Specialist

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

Meet the team:

Regulatory Affairs is a team of more than 40 professionals located either at San Diego HQ or remotely around the globe. Our backgrounds range from biological and physical sciences to engineering, political science to biostatistics, pharmacology to law just to name a few. Our degrees include Bachelor’s, Master’s, Ph.D.’s, JD’s and more. With our various backgrounds and talents we help to navigate and align the ideas and output of most facets of the company to successfully get our home-use products to our end users. We’re closely connected with QA, Clinical, IT, and Global Business Solutions (GBS) under the same Executive Vice President. At our quarterly onsite gatherings, some of our pastimes include story sharing, cooking and baking, social events and other team-building activities.

Where you come in:

• You will support developmental activities for Dexcom software products.
• You will develop regulatory strategies and prepare submissions in various countries (US, EU, Canada).
• You will collaborate with regional regulatory teams to develop global strategies as required.
• You will review and approve product and promotional labeling for software.
• You will represent Regulatory Affairs on various cross-functional software teams.
• You will review and approve software documentation and evaluate for submission requirements.
• You will take on additional projects and responsibilities as needed.

What makes you successful:

• You bring knowledge of US and international regulatory requirements including design control, medical device submission requirements, labeling and promotion regulations, and medical device quality systems.
• You have Medical Device Software experience and/or knowledge, such as software development lifecycle, IEC 62304, and software classification.
• You have strong technical writing, editing, and analytical skills.
• You work well independently and with cross-functional teams.
• You thrive in a fast-paced environment and adapt quickly to changing priorities.
• You are proficient in problem solving, proactive learning, organization, and have excellent communication skills.
• Having previous experience with 510(k) submissions, Health Canada submissions, or EU Medical Device Regulation is preferred.

What you’ll get:

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• 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.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Travel Required:

• 5-15%

Experience and Education Requirements:

• Typically requires a Bachelor’s degree and a minimum of 2-5 years of related experience.

Flex Workplace:

• Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).

Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

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. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [e-mail].

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [e-mail].

Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true

AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

Salary: $71,600.00 - $119,300.00