Company DescriptionEstablished in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30 offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.Job DescriptionPosition Responsibilities: • Electronically process events to determinecomplaint and reportability status. Complete applicable Medical Device Reports(MDR) as required per internal policy & procedures and FDA regulations. • Ensure complaint investigations are adequate,accurate, detailed and timely. • Perform tasks to obtain adequate informationto ensure proper documentation and closure of each complaint. • Collaborate with appropriate technical,Clinical, Field/Sales and/or returned product analysis employees to determine reportingeligibility. • Complete electronic submission of MDRs to theFDA. • Ensure accurate data entry, scanning, andretention of documents to complete event files. • Support internal systems, methods, andprocedures to maintain compliance. • Develop and maintain product knowledge of CRHFproducts. • Assist in inspection support for FDA andglobal regulatory agencies. This may include research and preparation ofcorrespondence in response to global regulatory agencies requests foradditional information. • Develop and maintain a working knowledge ofregulations and standards related to post-market quality & complainthandling. • Complete projects as assigned and requiredspecific to post-market quality and complaint handling. QualificationsBasic Qualification: Education Required: Bachelor's Degree Years Of Experience: Less than one year experience in a health, clinical,technical, or scientific field with a Bachelor’s Degree Additional InformationIf you want to apply and want to know more, please contact:Sagar Rathoresagar.rathore(AT)collabera.com630-485-2166