MDR/Vigilance Specialist

Established 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. Position Responsibilities: • Electronically process events to determine complaint 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 information to ensure proper documentation and closure of each complaint. • Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility. • Complete electronic submission of MDRs to the FDA. • Ensure accurate data entry, scanning, and retention of documents to complete event files. • Support internal systems, methods, and procedures to maintain compliance. • Develop and maintain product knowledge of CRHF products. • Assist in inspection support for FDA and global regulatory agencies. This may include research and preparation of correspondence in response to global regulatory agencies requests for additional information. • Develop and maintain a working knowledge of regulations and standards related to post-market quality & complaint handling. • Complete projects as assigned and required specific to post-market quality and complaint handling. Basic 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 If you want to apply and want to know more, please contact: Sagar Rathore sagar.rathore(AT)collabera.com 630-485-2166