Job Description

Primary Responsibilities: Coordinates complaint intake, evaluation, and investigation activities Assesses complaints for Medical Device Reporting (MDR), Mandatory Problem Report (MPR), and Vigilance reporting requirements Prepares and submits MDR / Vigilance reports to US and global agencies as required. Authorizes closure of complaints. Manage the intake and review of recall response forms, including trending and status updates to management. Escalates issues that may require corrective action. Generates quality data for product quality trending and improvement opportunity. Management of complaint, Medical Device and Vigilance Reporting Files Provides training for complaint intake and returned device evaluation Interacts with Customer Care to support complaint data intake requirements and complainant follow-up Manages input and follow up of all complaints Assist in the validation of the electronic complaint handling system Skills Required: Strong English verbal and written communication skills Demonstrate strong critical thinking skills to evaluate and investigate customer complaints, determining the need for CAPA and MDR Demonstrate excellent people skills including ability to probe with questions for information Knowledge of complaint handling and reporting requirements as defined within the following: 21 CFR §803 (US) 21 CFR Part §820.198 (US) Canadian Medical Devices Regulations, SOR 98/282 MEDDEV 2.12-1 / EUMDR Japan MHLW Ministerial Ordinance No. 169 Taiwan Pharmaceutical Affairs Act article 45 and article 45-1 Section 41FN(3)(d) of the Therapeutic Goods Act 1989 complaint handling and reporting requirements ISO 13485:2016, Medical Devices - Quality Management System Demonstrate knowledge in a manner that helps others know how to comply with requirements - assist mode Show willingness and ability to learn new processes and suggest options for compliance and efficiency Excellent Analytical skills and ability to synthesize trending data into meaningful information for the organization Demonstrated leadership; attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects Learn and implement company policies, procedures and work instructions Qualification required: Bachelor Degree in a scientific discipline, nursing or medical technician preferred Experience Required: 3+ Years' experience in Medical Device/Pharma Industry with experience in QSR, C