Global Complaint Management

The role of Analyst, Global Complaint Management (Customer Response) within the Quality team as an Associate based in Chennai, India involves managing device or pharmaceutical complaints and adverse events on a global scale. Your responsibilities include initial triage of complaint files, assessing reportability, escalating customer advocacy events, submitting regulatory reports as per applicable regulations, referring potential safety cases, obtaining additional information for events, providing updates to reports, and ensuring timely processing of complaint files for regulatory reporting purposes. In this role, you will be required to draft and send professional and clear responses to customer complaints related to medical devices, gather additional information when necessary, and ensure compliance with regulatory standards and timelines. You will handle customer advocacy issues and escalate complex events to the Specialist or Team Lead. Providing accurate information to customers verbally and in writing, overseeing event management, coordinating with subject matter experts and the GCM Specialist/Team Lead for event resolution will be part of your duties. It is essential to stay updated on company policies, including Information Security Management Systems, while maintaining the confidentiality and security of all company and customer information. Your writing skills are crucial for drafting responses to customer complaints, creating customer letters, and writing complaint narratives. Familiarity with medical terminology and products used in clinical settings is beneficial. Effective communication skills are required to interact with bio-medical engineers and health care providers to gather detailed data. Critical thinking skills are essential to determine the right questions to ask and to collect, analyze, and interpret complaint and adverse event information. Proficiency in writing narratives and creating customer letters, good computer and keyboarding skills, as well as excellent telephonic and listening skills are necessary for this role. A Science or Medical Engineering graduate or a graduate of Allied Science with a Bachelor of Science Degree in Nursing, Bio-Medical Engineering, Pharmacy, Medical Technology/Clinical Laboratory Science is required. Experience in a healthcare environment, quality/compliance/regulatory organization in an FDA regulated business, and 3-7 years of experience in a similar role, preferably in a medical device organization, are preferred qualifications. Minimum qualifications include being at least 18 years of age and passing a pre-employment background check. This role is predominantly sedentary and operates in a professional office environment using standard office equipment routinely.,