Medical Device Reporting Analyst

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Location :
Plattsburgh, New York

Expiry Date :
Sat, 05 Dec 2020 23:59:59 GMT

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Description :
Job Summary The QA/RA MDR Coordinator supports all Hill-Rom entities in determining reportability of complaints and ensuring on time regulatory reporting. Essential Duties And Responsibilities – Manage and maintain an efficient Medical Device Reporting work flow in order to achieve complete, accurate and timely medical device reporting. – Draft and submit Medical Device Reports to the FDA and Medical Device Problem Report to Health Canada for Batesville, Monterrey, Singapore, Pluvigner and Liko products. – Draft Clinical Evaluations for complaints, communicating with users and Hill-Rom clinical staff. – Support all Hill-Rom entities in relation to Clinical Evaluations, reportability determination, navigating the electronic complaint handling system. – Provides support to the Post Market Surveillance complaint analysts related to product knowledge and reportability. – Draft and review regulatory responses related to Post Market Surveillance. – Maintain metrics for the Adverse Event reporting process. – Support internal and external audits. – Provide support to the eMDR process and software working with IT. – Other duties as assigned. #INDHR Required Experience, Education And Qualifications – Bachelor’s degree or equivalent work experience. – 2+ years working in the medical device industry or related GMP environment or equivalent preferred. – 2+ years of relevant work experience in a Quality, or Regulatory role preferred. – Proficiency with Microsoft systems (Excel, PowerPoint, and Word) required. – Experience with documentation and technical writing skills, in a regulated compliance environment, is preferred. – Ability to communicate between various organizations and work with multifunctional teams, including senior leadership. – Excellent organizational skills and ability to plan and implement resolutions to problems. – Clinical experience required. Hillrom is a $2.9B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hillrom’s comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care. Hillrom is an equal employment employer F/M/Disability/Vet/Sexual Orientation/Gender Identity Job Quality Primary Location United States-Illinois-Chicago, IL Other Locations United States-Indiana-Batesville, United States-New York-Skaneateles Falls Schedule Full-time Travel No Posting Entity Hillrom