VIGILANCE SPECIALIST

Job description

Job title: Associated MDR/Vigilance Specialist Location: Mounds View, MN Duration: 12+ months (Possibility of extension) ROLES & RESPONSIBILTIES · Participates in the company's medical device and/or drug surveillance platform; including the intake, evaluation, processing, and follow-up on product performance events, complaints, and adverse reports. · The MDR Specialist analyzes events reported from multiple inputs on Cardiac Rhythm and Heart Failure Management (CRHF) products to determine complaint status and regulatory reportability. · In addition, this position supports the ongoing monitoring of product performance. · Works cross-functionally to ensure maintenance and review of events and complaints, reporting of Medical Device Reports (MDRs), ADE data, or adverse reaction data, as set forth by the FDA and other regulatory agencies. · Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. · Supports and represents complaint handling in internal and external audits and inspections. As part of the Cardiac and Vascular Group Product Experience Management organization, we seek candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action. 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. ***Required*** · Bachelor's Degree · At least one year experience in a health, clinical, technical, or scientific field · Can work independently in a team environment · Attention to detail · We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job. Thanks & Regards, Seema Chawhan Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I DIRECT # - 732 – 318 -6506 | (W) # 732-549-2030 – Ext – 324 | (F) 732-549-5549 Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.