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
Bring your safety, quality and regulatory expertise to this role, with DexCom Inc. Customer Advocacy and Quality, and other relevant teams, to establish, maintain and improvement DexCom Japan's Good Vigilance Practice (GVP) process, and to execute and lead safety activities as Japan Safety, Sr Safety Specialist.
Where You Come In
- Based on the Japanese Regulations including J-PMD Act, Enforcement Ordinance of J-PMD Act, QMS Ordinance and GVP Ordinance, you will execute and lead DexCom Japan's GVP activities for supporting GVP manager.
- Systematically review and analyze complaint records at all complexity levels for possible product malfunction/safety issues to ensure accurate classification and post-market product performance trending.
- Assist in leading and may provide guidance on complaint investigations and support less senior team members. (Leads daily activities related to PMDA or third-party inquiry response drafting.)
- Build and maintain relationships with key stakeholders in post-market surveillance as it relates to complaint handling and product performance, collaborating with Customer/Technical Support, Field Failure Analysis, Quality Assurance, Quality Compliance, Regulatory, and Marketing & Commercial Teams. (Collaborate with global teams in providing and/or receiving updates related to Complaints Handling and SAE processing.)
- Evaluate current processes to identify inefficiencies, bottlenecks, and areas for improvement.
- Analyze data and metrics to understand performance trends and areas needing attention.
- Establish standardized frameworks and methodologies for process improvement initiatives.
- Promote knowledge sharing and cross-departmental collaboration to leverage lessons learned. (Leads daily activities related to PMDA or third-party inquiry response drafting.)
- Partner cross-functionally to support the deployment of methodologies and tools, such as robotic process automation efforts and complaint system updates to promote operational excellence and scalability throughout the global Customer Advocacy organization.
What Makes You Successful
- You can demonstrate high-level proficiency post-market product surveillance activities as they relate to complaint handling and global health authority reporting in compliance with all domestic and international regulations
- You have ability to work independently with minimal supervision and as a team player within a department as well as with other departments.
- You have analytical with ability to define problems, collect data, establish facts, and draw valid conclusions.
- You have ability to articulate progress, challenges, and solutions effectively to leaders or colleagues.
- You have ability to manage and prioritize multiple projects and tasks in a fast-paced environment.
- You are able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary. Strong Self-Leadership, Logical thinking and problem-solving skill
- You have strong verbal and written communication skills in Japanese (Native level) and English (Business level at least)
Experience And Education Requirements
- You must have at least five (5) years' experience of Complaint Handling and Vigilance Reporting activities in medical device / IVD industry.
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.
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