Associate - Complaints Management Job in Indegene

Associate Complaints Management You will be responsible for: Follow a streamlined and compliant complaint-handling process in alignment with regulatory requirements, including EU MDR and ISO 13485. Ensure the efficient receipt, documentation, and registration of customer complaints via various channels (phone, email, website). Categorize and prioritize complaints based on severity and potential impact on patient safety and product quality. Collaborate with cross-functional departments, including Quality Assurance, Regulatory Affairs, and Product Development, to gather necessary information for investigation. Maintain comprehensive and meticulously organized records of all complaint-related activities, including investigations, findings, and resolutions. Ensure records are compliant with regulatory standards and are readily accessible for audit and review purposes. Prepare and communicate regular reports on complaint trends, analysis, and resolution status to senior management. Maintain open and transparent communication with complainants, providing updates on complaint progress and resolution timelines. Stay abreast of evolving medical device regulations and standards, ensuring the complaints handling process remains compliant. Your impact: About you: Strong knowledge of regulatory requirements, including EU MDR and ISO 13485. Excellent problem-solving and analytical skills. Exceptional interpersonal and communication skills. Proficiency in complaint tracking software and Microsoft Office Suite. Must have: Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering, Quality Management); Master's degree preferred. 3+ years of experience in medical device complaints handling