Job Details Posting Date: 05-Mar-10
Job ID # 130485  
   
Company: Baxter Healthcare Contact Name: Human Resource
Address 1: One Baxter Parkway Phone:
Address 2: Fax:
City/State/Zip: Los Angeles CA 90039 E-Mail: timothy_flynn.69713.2451@baxterna.aplitrak.com
  Web Site: http://www.aplitrak.com/?adid=dGltb3RoeV9mbHlubi42
   
Job Type: Job Title: Product Surveillance Nurse
Category: Health Care  
   
Job Responsibilities/Duties:
Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. Job Description This position is responsible for managing in-depth complaint investigations, with expert product knowledge. This role is responsible for report submissions to regulatory bodies and providing information to Baxter business units for decision-making purposes. This position is a subject matter expert in the team and will train and mentor other Product Surveillance Quality Associates. " Process high-risk (Death/Serious Injury) complaints without supervision " Determine reportability of a complaint and submit associated Medwatch reports within 30 days per regulations " Lead the investigation, including developing investigation plan, defining members of investigation team and their roles and responsibilities, plan on-site visits, follow-up communication with internal and external customers  
 
Qualifications:
" Expert knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820 and 211.) Understanding of regulations governing markets outside the U.S. " Expert understanding of the product's intended use and manufacturing process of assigned products. Ability to prioritize multiple high risk projects to ensure compliance with regulations and standard operating procedures. Excellent problem solving and analytical skills. " Bachelor's degree in Nursing or Medical Technology is required. 7 years experience, which should include Product Surveillance, direct clinical/medical experience, or relevant product/technical expertise. Experience managing CAPA is preferred. " Travel to customer sites to obtain information pertinent to the investigation, including sample, clinical and engineering information " Guide Specialists leading high-risk investigations, review Medical Device Reports associated with death and serious injury. " Produce and maintain annual base line reports, Alternative Summary Reports and 24-Month Reports as required by the Medical Device Reporting regulation " Perform trend reporting and escalate results to appropriate business units for consideration of necessary actions. " Represent Product Surveillance on Product Improvement Teams, as well as CAPA. Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.  
 
Contact Information: 
To apply to this position, please do so directly at: http://www.aplitrak.com/?adid=a2F0ZV9ib29oZXIuNjU3NzEuMjQ1MUBiYXh0ZXJuYS5hcGxpdHJhay5jb20  
 
   
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