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Milpitas, CA, US

Medical Surveillance Specialist I (Milpitas, CA)-0985130208

Description

LifeScan, Inc., a member of Johnson & Johnson Family of Companies, is recruiting for Medical Surveillance Specialist I, located in Milpitas, CA.

As the market leader and maker of blood glucose monitoring systems for home and hospital use, LifeScan, Inc., a Johnson & Johnson Company, is dedicated to improving the quality of life for people with diabetes through our OneTouch® Brand of blood glucose monitoring systems. The ONETOUCH® Brand of consumer and institutional products includes portable electronic meters and disposable reagent test strips to provide accurate glucose readings, and also the software tools to transform this information into actionable health care decisions. To find out more about LifeScan, please visit our website at www.LifeScan.com.

This position works independently but with general supervision to prepare and submit Medical Device Reports (MDRs) to global Health Authorities. The individual ensures global reportable complaints for LifeScan/Animas are processed and submitted accurately, and on time to global Health Authorities, and acts as a resource for Customer Service regarding Potential Reportable complaints.

Using discretion and independent medically-based judgment, the Medical Surveillance Specialist I reviews, evaluates, classifies potential reportable complaints as adverse event, product malfunction or rule-outs for both U.S. and International affiliates. They will evaluate global potential reportable complaints demonstrating sound judgment to determine if the reporting requirements for global medical device reports are met, and are responsible for timely regulatory reporting, collaboration and teaming, and accurate/precise documentation.

The successful candidate processes MDR's/MDV's and rule-outs within the NorthStar system and files MDR's/MDV's with global Health Authorities as required, as well as notifies the appropriate international representatives when reports must be filed with their local health authorities.

The incumbent communicates with global customer/technical service representatives and with the end-users when clarification is required, confers with co-workers and MDs to reach a decision regarding a potential reportable complaint's classification, and acts as a potential reportable complaint resource to the global Customer Service Department. This includes but is not limited to addressing questions about potential reportable complaints and advising on Potential Reportable documentation.

Other duties required are initiating queries for the daily tracking of Potential Reportable complaints, and may execute test cases involving the NorthStar software, as well as being responsible for other duties assigned, as needed.

Qualifications


A Bachelor's degree in health-related science or life science from an accredited school/ university / college; or Licensure, registration, or certification by a state, territory, or other governing body to administer health care is (i.e. RN, RD, CDE, RT, CNA, or MA) required. A minimum of 2 years of experience in a medical field (RN, RD, CDE, RT, CNA, MA), patient education, or as a LifeScan/Animas Customer Service Representative is preferred. Sound business judgment and the ability to make independent decisions to ensure compliance with FDA and global Health Authority reporting requirements are required. Excellent verbal and written communication skills in English are required. Excellent attention to detail is required. Excellent interpersonal, problem-solving, and organizational skills are required. Proficiency in the use of technology including keyboarding, PC's, Internet, word processing, email functionality, etc. is required. Fluency in an additional language (especially Spanish) would be an asset but is not required. Knowledge of diabetes and medical terminology is strongly preferred.

Primary Location:North America-United States-California-Milpitas
Organization: Lifescan Inc. (6097)
Job Function: Medical Affairs