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This position requires meticulous attention to detail, a strong clinical background, and the ability to navigate complex medical data and regulatory requirements effectively. The ideal candidate will be proactive, detail-oriented, and capable of working both independently and collaboratively within a dynamic team environment.
Job Responsibility:
Process consumer complaints related to enteral feeding medical devices in accordance with applicable regulations
Collect, assess, and document medical device complaints and adverse events promptly and compliantly
Conduct follow-up calls with customers to gather additional details on adverse events and complaints
Code complaints using relevant dictionaries and input data into electronic complaint databases
Perform medical safety assessments and risk analyses for medical device complaints
Prepare and present medical safety reports, analyses, and assessments to internal stakeholders
Determine the reportability of complaints to regulatory authorities and ensure timely vigilance reporting
Requirements:
Bachelor of Science in health sciences or a related field
3-5 years of clinical experience as a Registered Dietitian or Registered Nurse
Strong knowledge and practical experience with enteral tube feeding and nutrition support
Ability to apply critical thinking and clinical expertise to analyze adverse event data and medical device assessments
Proficient in computer skills (Windows, Word, Excel)
Excellent communication skills for presenting medical and scientific data both orally and in writing
Demonstrated ability to work collaboratively in a multidisciplinary team
Capable of working independently with minimal supervision
Nice to have:
Previous experience in industry or clinical case processing
Familiarity with medical devices and relevant device regulations
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