Data Analyst Lead

  • Experience Range: 2-10 Years
  • Job Location: HCM
  • Duty & Responsibilities:

    – Intake and Evaluation of Medical product complaints
    – Follow-up with customer for missing details in Medical Product complaints
    – Identification of applicable medical coding, regulatory standards, and requirements for said Medical devices
    – For the given compliant detailed data analysis of problem statement and based on the regulatory coding guidelines identify the corresponding medical coding
    – Classification of Medical Devices based on USFDA, EU and other National/Regional regulations
    – Receive product complaint information from different complaint sources and assign to the team members for complaint entry / update
    – Attention to detail in assessing the complaint information and follow-up to collect relevant information from the complainant source
    – Confirm the entry/update is completed and coordinate with the customer / complaint source for follow-ups as needed.
    – Review and confirm the device and patient codes in the complaint file based on the reported event information / additional information
    – Ensure all the obtained follow-up information are updated in a timely manner. –
    – Ensure the re-assessment reportability is performed based on received additional information
    – Ensure that complaints are moved to next stage of complaint handling processing in a timely manner
    – Generate status reports and communicate the dependencies and resolve them in timely manner
    – Participate in status meetings for the project

  • Reqirements:

     Educational Qualification: Graduate in Science or Engineering (Bio-Medical, Mechanical)
     Knowledge on ISO 13485, Post Market Surveillance, Medical Complaint Handling
     Handled product complaints of medical devices.
     Prior experience in FDA regulated industry including medical complaint handling.
     Knowledge on MDR / adverse event reporting
     Experience with Trackwise or electronic complaint management tool.
     Knowledge on medical device quality assurance
     Hands on experience in direct customer co-ordination during the review / clarification meeting
     Good interpersonal skills and communication skills
     Should have lead a team of 8 – 10 members
     Ability to work in a timeline driven environment
     Good in English – Communication and Writing Skills

  • Benefit:

    – Insurance plan based on full salary + 13th salary + Performance Bonus.
    – 100% full salary from the 1st day of working and during WFH.
    – Medical Benefit (Bao Viet Insurance package) for Employee and Family.
    – Working in a fast paced, flexible, and multinational working environment. Chance to travel onsite (in 49 countries).
    – Internal Training (Technical & Functional). Scope of English Training.
    – Working time: 8:30 am-6:00 pm from Mondays to Fridays.
    – 18 paid leaves per year (including 12 annual leaves + 6 personal leaves)

  • Preferred Language for Application: English

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