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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.
Summary:
To provide support to independent medical safety assessment for Dexcom products by proactively obtaining, reviewing and evaluating additional data and reports containing potential safety information. To support individual case global safety / regulatory reporting compliance. To support quality system post market surveillance plan. To provide support to Health Care Professionals and Dexcom patients, who require immediate assistance due to device issues with potential health implications.
Essential Duties and Responsibilities:
Assure medical validity and provide input to the activities of Customer Advocacy and Quality teams.
Following documented procedures, produce and document medically accurate assessments to include elements such as coding, causality, seriousness, and case narratives.
Triage and appropriately escalate product complaints that require elevated review and safety signals.
Execute post market surveillance activities in compliance with applicable global regulations, such activities include post market plans, PSUR, CER, literature reviews, design control, and risk management.
Review and provide input on any complaints regarding serious adverse events. Contact medical professionals for additional information as required.
Execute medical triage for appropriate causality on investigational assessment documents supporting regulatory reporting.
Assist in providing safety trend analyses and any related periodic review meetings.
When indicated, review technical support calls and communicate potential issues with technical support management.
Performs other duties related to the position as necessary as defined in company’s SOPs or requested by his/her supervisor.
Preferred Qualifications:
Knowledge of and clinical experience in field of diabetes and CGM technology are desirable.
Experience in Safety Vigilance monitoring and Adverse Event case processing/reporting or Quality Assurance are desirable.
Experience in Post Market Surveillance activities is desirable.
Ability to interpret company policies and procedures to complete a variety of tasks.
Must be self-motivated, self-confident, and be able to work independently or equally well as a team member. Demonstrated ability for teamwork and collaborative problem-solving.
Other important qualities include excellent written and verbal communications skills, attention to detail, consensus building and teamwork, planning and implementation skills.
Registered Nurse preferred
Minimum 2-5 years of previous clinical work experience
2 or more years of experience in Post Market Surveillance, Medical Device Reporting and Product Vigilance monitoring is highly desirable
Travel Required:
0 – 25%
Education Requirements:
Typically requires a Bachelor’s degree and a minimum of 2-5 years of related experience.
Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.
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:
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