Complaints Coordinator

• Responsible for day-to-day complaint management of quality, technical and adverse event complaint records, including intake, follow up, triage and entry, in accordance with local and international regulations, guidelines, and applicable directives. 
 • Receive initial complaint from any source (external and internal) and ensure all information/data is accurately captured at point of contact 
 • Maintain an understanding of information/data required to be collected for technical and adverse events/ reportable complaints to ensure compliance with regulations and directives. 
 • Review complaint data, assess for reportability and escalate to the safety teams for reportability assessment. 
 • Performs intake / follow up / data entry activities and attaches corresponding source documents in a timely manner per requirements and directives. 
 • Triage call from all sources for quality technical complaint, Adverse Event, request for refund, request for replacement product and request for credit. 
 • Reviews data entry and follow-up activities for completeness and timeliness 
 • Closes files according to established guidelines to meet required timelines 
 • Maintains a working knowledge of company policies and procedures, departmental processes, and associated procedures and work instructions ,IGT devices for IFUs, Manuals, Promotional Material; coronary and therapeutic procedures 
 • Informs management of potential safety issues, emerging trends and/or concerns 
 
 This is a complaints coordinator position (not customer service rep II) for medical device products 
 
 Minimum requirements 
 • Bachelor's degree or equivalent years of directly related experience 
 • English 
 • Minimum of 2-3 year directly related experience 
 • Knowledge of FDA/QSR requirement & quality systems in Pharma and/or Medical device experience required (i.e. 21 CFR Part 820, Quality System Regulations , 21 CFR Part 803, Medical Device Reporting , The Privacy Rule, HIPAA , ISO 13485) 
 • Solid knowledge of word processing, spreadsheet, database and presentation applications 
 • Good organizational skills a must. Effective communication skills needed to provide clear and concise information to team members 

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