The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet The Team
The Regulatory Affairs Specialist will work within Regulatory Affairs and with cross functional teams to support RA efforts as part of Dexcom’s MLR review process (medical/legal/regulatory). The Regulatory Affairs Specialist will be responsible for review of advertising and promotional materials to ensure compliance to applicable regulations. The Regulatory Affairs Specialist also supports coordination cross functionally to facilitate online and offline review meetings with authors, reviewers/approvers for timely content approval in support of business needs. The RA specialist performs librarian duties as directed to maintain accurate updates to the advertising and promotional library.
Where You Come In
- You will support review of advertising and promotional material in accordance to internal procedures as part of the MLR review process.
- You act as SME for Dexcom’s products and regulatory requirements for promotional activities
- You can provide guidance to material authors and reviewers on regulatory and internal policy requirements.
- You also help facilitate alignment of global product claims across regional SMEs
- You help support process improvement by working with cross functional team to make changes to current process pain points and optimize review efficiency
- You will monitor changes with applicable US and international regulations and standards. You provide summaries for these changes to inform compliance needs and best practices for advertising and promotional review.
- You can create reports & metrics to provide visibility to marketers, reviewers and management on process efficiency.
- You will perform other duties as assigned.
What Makes You Successful
- You have experience with regulated medical device industry, and experience in Advertising & Promotional labeling requirements
- You have excellent writing and verbal communication skills, strong attention to detail, highly organized, and experience managing projects within a cross functional environment.
- You have knowledge of 21 CFR regulations, EU MDR
- You are interested in the medical device industry, diabetes care, business system best practices
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
Experience And Education Requirements
- Typically requires a Bachelor’s degree and a minimum of 2-5 years of related experience.
- Regulatory Affairs experience is preferred. Advanced degree in may substitute for years of 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 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.
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
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.
Salary
$71,600.00 - $119,300.00
