Associate / Analyst

Role Overview: You will be responsible for overseeing complaint management and adverse event reporting. Your core activities will include initial review and categorization of complaints, determining reportability, escalating customer issues when necessary, preparing and submitting regulatory reports, coordinating with safety teams, collecting supplementary case data, updating reports, and ensuring all complaint files are processed accurately and within reporting timelines. Key Responsibilities: - Prepare and send clear, compliant written responses to customer complaints regarding medical devices, while gathering any missing details needed for complete case assessment. - Address customer concerns promptly and escalate complex or high-impact cases to the Specialist or Team Lead for guidance. - Deliver precise and professional information to customers through verbal and written communication. - Manage the entire complaint lifecycle from event recording and customer follow-up to case closure or reopening when necessary. - Coordinate with Subject Matter Experts (SMEs) and Specialists/Team Leads to ensure effective case resolution. - Stay current with and adhere to all organizational policies, including those related to information security and data privacy. - Safeguard the confidentiality and integrity of company and customer information at all times. Qualification Required: - Exceptional writing ability to compose clear complaint narratives, customer letters, and other documentation. - Familiarity with medical terminology and understanding of how medical or pharmaceutical products are used in clinical settings. - Strong communication skills to engage effectively with biomedical engineers and healthcare professionals for case-related details. - Analytical and critical thinking capability to identify necessary questions, gather relevant data, and interpret complaint and event information accurately. - Competency in drafting complaint summaries and customer communications. - Proficiency in computer usage and documentation systems, with strong typing accuracy. - Excellent listening skills and a professional telephone manner. Additional Details: No additional details provided in the job description.,