– 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

 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

– 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)