Job Title

Job Purpose:To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction.Key Responsibilities:- Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. - Acknowledge receipt of complaints and communicate resolution timelines to complainants. - Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. - Coordinate with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s). - Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines. - Document complaint details, investigation findings, corrective actions, and outcomes. - Communicate findings and resolutions to stakeholders and customers. - Generate monthly/quarterly complaint trend reports and risk assessments. - Support external/internal audits and regulatory inspections by providing complaint-related documentation. - Maintain compliance with company SOPs, ISO standards, and regulatory requirements. - Recommend preventive actions and contribute to quality improvement initiatives.Required Qualifications and Skills:- Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field. - 3+ years of experience in product complaint handling, preferably in the medical device or pharmaceutical industry. - Knowledge of ISO 13485, FDA regulations, MDR, and other global regulatory requirements. - Strong analytical, problem-solving, and documentation skills. - Familiarity with complaint management software or QMS tools (e.g., TrackWise, MasterControl, etc.). - Excellent communication skills – written and verbal. - Attention to detail and a commitment to quality and compliance.Preferred Qualifications:- Certification in Quality Management Systems or Regulatory Affairs. - Experience in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). - Exposure to CAPA, NC, and audit handling processes.