Associate, Global Complaint Management (Customer Response) ICU Medical, Inc.

3.0 - 7.0 years

0 Lacs

chennai, tamil nadu

On-site

The position of Analyst, Global Complaint Management (Customer Response) in the Quality team in Chennai, India, requires you to manage device or pharmaceutical complaints and adverse events on a global scale. Your responsibilities will include initial triage of complaint files, assessments of reportability, escalating customer advocacy events, submitting regulatory reports, obtaining additional information for events, providing updates to reports, and ensuring timely processing of complaint files for regulatory reporting. You will be expected to draft and send clear responses to customer complaints, handle customer advocacy issues, and escalate complex events as needed. Additionally, you will coordinate with Subject Matter Experts (SMEs) and GCM Specialist/Team Lead for event resolution, ensuring compliance with company policies and maintaining confidentiality of information. To excel in this role, you must have strong writing skills for drafting responses and complaint narratives, knowledge of medical terminology, and the ability to communicate effectively with bio-medical engineers and healthcare providers. Critical thinking skills will be essential in gathering necessary information and analyzing complaint and adverse event data. Proficiency in computer skills, telephonic communication, and active listening is also required. The ideal candidate should hold a degree in Science, Medical Engineering, or Allied Science, with a preference for a Bachelor of Science Degree in relevant fields. A minimum of 3-7 years of experience in a similar role, preferably in a medical device organization, is desired. Applicants must be at least 18 years old and pass a pre-employment background check. This role is primarily sedentary and operates in a professional office environment using standard office equipment. It is crucial to stay updated on information security management systems and adhere to regulatory standards while ensuring customer satisfaction and event resolution.,

Posted 3 weeks ago

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Global Complaint Management ICU Medical, Inc.

3.0 - 7.0 years

0 Lacs

chennai, tamil nadu

On-site

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.,

Posted 1 month ago

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