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General Electric Clinical Product Surveillance Leader. in Bengaluru, India

Role Summary:Combines skills in post market and clinical product knowledge in handling incoming complaints and assessing risk. Provides guidance to a cross functional team on clinical workflow and how products are used to identify potentially hazardous situations in complaints and promote a high level of customer focus and understanding

Essential Responsibilities:1. Evaluate complaints from patient safety perspective and identify complaints that require further evaluation under 21CFR part 803 (MDR)2. Provide clinical expertise to the complaint handling unit to assist in proper evaluation of customer complaints3. Analyze data on patient safety and risk, ensuring compliance with applicable postmarket regulations4. Assist in and coordinate a multidisciplinary approach in reportability determinations5. Responsible for hazard evaluations6. Participate in and approve Risk Assessments7. Ensure customer communications are created and issued; review customer responses for technical accuracy related to GE products8. Follow-up with the end user / customer9. Collaborate with Medical Director and other Clinical staff to identify and document severity and likelihood of harm in the RAC document10. Responsible for the continuous clinical education of the team11. Assist in reviewing and auditing complaint records for accuracy as well as hazardous situations

Qualifications/Requirements:1. Bachelor's degree in medical science, heath sciences or healthcare related field and a minimum of 6 years of clinical experience; OR Bachelor's degree in medical science, heath sciences or healthcare related field and a minimum of 3 years of clinical experience and a minimum of 3 years of QA/RA experience in the medical device industry

Desired Characteristics:1. Product-specific knowledge 2. Registered Nurse or CRNA or Registered Radiologic Technologist3. Demonstrated knowledge of 21CFR Part 8204. Ability to demonstrate GEHC Growth Values5. Ability to quickly assess situations and make decisions6. Demonstrated program management or leadership skills7. Understanding of the clinical environment and product work flow8. Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment9. Ability to work independently & in a team setting 10. Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing).11. Excellent interpersonal, organizational, and influencing skills 12. Familiarity with the application of medical device as it relates to patient safety13. Ability to analyze and process data, and draw the appropriate conclusions14. Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems15. Ability to analyze and process data, and draw the appropriate conclusions16. Prior experience working with Microsoft Office products17. Working knowledge of GEHC products

About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.comAdditional Locations:India;Bengaluru;

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