PMS Service – Medical Devices Complaints Handling

Job Position: PMS Service – Medical Devices Complaints Handling Job Description: To handle medical device customer allegations in complaints management system . Candidate with knowledge on Medical devices usage, Complaint Evaluation, Investigation, Medical devices reporting including post-market surveillance (PMS) and CAPA.Roles and Responsibilities:To work on Complaint handling Process – Evaluation, Regulatory Assessment, InvestigationWork with lead in completing daily assignation.Organize and manage daily work allocationComplaints remediation using work instruction, compliance to processTo drive efficiency and compliance.Collaborate with of cross function team (CFT) such as Intake, MDR, Investigation to execute the project and initiative.Daily status to lead associateSkills:2 to 4 years of experience in Medical devices complaints handling or any PMS activitiesWorking knowledge of appropriate global medical device regulations, requirements, and standards such as: CFR Parts 803, 806 and 820, ISO 13485, ISO 14971, EU Medical Device Directives/Regulations including MEDDEV GuidelinesFor Complaint Investigation – Mechanical problem analysis skill neededAn excellent communicator, both written and verbal Adopt to cross cultural differencesAbility to work in a timeline driven environmentProficiency using tools such as Trackwise, Sales force, Service Max