Customer Advocacy Specialist 医療機器 安全管理 GVP

Posted:
12/2/2024, 4:00:00 PM

Location(s):
Tokyo, Japan

Experience Level(s):
Junior ⋅ Mid Level

Field(s):
Customer Success & Support

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:

Join our dynamic, innovative, and purpose-driven multinational organization! As part of our team, you'll shape and influence real change for individuals living with Diabetes while enjoying long-term career prospects. Bring your safety expertise to establish, maintain and improvement DexCom Japan’s Good Vigilance Practice (GVP) process, and to execute and support safety activities as Japan Safety Specialist.

Where you come in:

  • You will assist in maintaining quality systems and driving continuous quality improvements.
  • You will gather, review, and analyze data for regulatory reporting, ensuring accuracy and compliance.
  • You will prepare and submit regulatory reports in adherence to medical device regulations and guidelines.
  • You will manage records of adverse events related to medical devices, ensuring timely reporting.
  • You will ensure proper documentation of all regulatory reporting activities and correspondence with regulatory agencies.
  • You will advise the company on compliance matters and identify opportunities for process improvement.

What makes you successful:

  • You must have at least three (3) years’ experience of Complaint Handling and Vigilance Reporting activities in medical device or IVD industry.
  • You have ability to perform routine tasks with accuracy and attention to detail.
  • You have logical thinking and problem-solving skill.
  • You have effective communication skills in English and Japanese, both written and verbal.
  • You have capability to read, interpret, and write reports and correspondence.
  • You are flexibility to work on routine assignments and adapt to changing priorities.

What you’ll get: (this section should not be modified)

  • 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: (Highlight the appropriate range)

  • 5-15%

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.

Dexcom

Website: https://www.dexcom.com/

Headquarter Location: San Diego, California, United States

Employee Count: 5001-10000

Year Founded: 1999

IPO Status: Public

Last Funding Type: Post-IPO Debt

Industries: Diabetes ⋅ Health Care ⋅ Health Diagnostics ⋅ Medical Device