Associate Manager - Complaints Management Job in Indegene

Associate Manager-Complaints Management You will be responsible for: Develop, implement, and maintain a robust complaint-handling process in compliance with regulatory requirements (e.g., FDA, ISO). Receive, document, and investigate all complaints related to our medical devices. Categorize and prioritize complaints based on severity and potential impact on patients and product quality. Collaborate with cross-functional teams to gather information necessary for complaint investigation and resolution. Lead and facilitate investigations into complaints, ensuring root cause analysis is conducted systematically. Work closely with R&D, Quality Assurance, Regulatory Affairs, and other relevant departments to develop effective corrective and preventive actions (CAPAs). Ensure timely and satisfactory resolution of complaints while maintaining a high level of patient and customer satisfaction Manage and mentor a team of Complaints Handling Specialists, providing guidance, training, and support. Set clear performance objectives and conduct regular performance reviews. Foster a culture of continuous improvement within the team. Maintain comprehensive records of complaints, investigations, and resolution activities. Prepare and present regular reports on complaint trends, analysis, and resolution status for senior management and regulatory authorities. Compliance and Quality Assurance: Stay current with all relevant medical device regulations, standards, and industry best practices. Implement and maintain quality assurance measures to enhance the complaints handling process. Customer Communication: Maintain open and transparent communication with customers throughout the complaint resolution process. Ensure customers are informed of complaint status and expected resolution timelines. Handle customer escalations with professionalism and empathy. Your impact: About you: Strong knowledge of FDA regulations (21 CFR Part 820) and ISO 13485. Excellent problem-solving and analytical skills. Exceptional interpersonal and communication skills. Leadership experience with the ability to motivate and develop a team. Proficiency in complaint tracking software and Microsoft Office Suite. Must have: Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management); Master's degree preferred. 7-10 years of experience in medical device complaints handling, with 2 years in a managerial capacity.