Regulatory Affairs Specialist
Dexcom, Inc

Job Info

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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.

If you join our team you will be supporting the growth and expansion of Continuous Glucose Monitoring (CGM) System.

Where you come in:

• You will participate in the development of regulatory strategies and prepare regulatory submissions:
  • US submissions include 510(k)s, IDEs, and Q-Subs
  • EU submissions include technical documentation filings and amendments
  • Other markets as required
• You will help create, review, and approve product labeling, including IFUs, packaging, promotional labeling, etc.
• You will represent Regulatory Affairs on various cross-functional teams:
  • Design Control - You will contribute to the development of the project plan and other deliverables. You will represent Regulatory Affairs in the development of Product Plans, Specifications, Risk Management, and other required documents. You will participate in Design Reviews as appropriate.
  • Document Control - You will represent Regulatory Affairs as a standing member of the Change Control Board (CCB). You will create and revise procedures as needed. You will review and approve change orders and evaluate for submission requirements.
• You will perform other duties as assigned.

What makes you successful:

• You bring knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submission requirements, labeling and promotion regulations, quality control, and medical device quality systems.
• You have Medical Device Software knowledge, such as software development lifecycle, IEC 62304, and software classification.
• You have strong technical writing, editing, and analytical skills.
• You must work well independently and within a cross-functional team environment
• You must be proficient in problem solving, proactive learning, organization, and have excellent communication skills.
• Having previous experience with US or international submissions 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.

Exempt Salary Details

The annual base salary range for this role is $38,000 to $63,400. Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand.

Experience and Education

• Typically requires a Bachelors degree and a minimum of 2-5 years of related experience.

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 talentacquisition@dexcom.com.

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 talentacquisition@dexcom.com.

View the OFCCP's Pay Transparency Non Discrimination Provision at this link.

UnitedHealthcare 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://transparency-in-coverage.uhc.com/.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

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