Senior Analyst

Role Overview: As a Complaint Management Specialist, 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 accurate processing of all complaint files within reporting timelines. Key Responsibilities: - Prepare and send clear, compliant written responses to customer complaints related to medical devices, ensuring complete case assessment. - Address customer concerns promptly and escalate complex 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 to case closure or reopening as needed. - Coordinate with Subject Matter Experts and Specialists/Team Leads for effective resolution of cases. - Stay updated with organizational policies, especially those related to information security and data privacy. - Safeguard the confidentiality and integrity of company and customer information at all times. Qualifications Required: - Exceptional writing ability for composing clear complaint narratives and customer letters. - Familiarity with medical terminology and understanding of medical or pharmaceutical products in clinical settings. - Strong communication skills to engage effectively with biomedical engineers and healthcare professionals. - Analytical and critical thinking capability to identify necessary questions, gather relevant data, and interpret complaint information accurately. - Proficiency in drafting complaint summaries and customer communications. - Proficient in computer usage and documentation systems with high typing accuracy. - Excellent listening skills and a professional telephone manner. Additional Details: No additional details are present in the job description.,