This is a 3 month contract with the possibility of turning into a direct position with our client. Overview: Complaint Handling Unit (CHU) member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. Additionally these activities may include Non-Conformance Investigations, Field Actions, Documentation Management and Metrics. The Complaint Specialist will be responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Complaint Specialist will communicate with Quality Engineers, Manufacturing, Product Development and other functional experts as needed to ensure clear understanding/investigation of applicable issues. Specific Responsibilities: Direct interface with in-house and field staff employees, surgeons and hospital personnel when taking complaint/adverse event information. Need to ask questions to ensure understanding of the event. Data entry of complaint/AE information into company database. Perform reviews of complaint investigations. Be proactive. Ask questions when assessing completed investigations for level of completeness. Be able to discuss and understand the investigation findings. Facilitate applicable documentation corrections as necessary to support compliance, using “good documentation practices”. Prior to closure, perform an analytical review of the complaint file. Prepare a complaint file summary addressing the alleged product complaint. Responsible for processing and closing complaints in a timely manner. Act as a CHU liaison with other departments for Post Market RA activities. Review trend data with Product Development and Manufacturing on a routine basis to ensure complaint trends are investigated and reported to management. Responsible for the maintenance of individual and departmental metrics, as applicable. Prepare, organize and summarize routine weekly, monthly, and quarterly reports for department management use. Ability to function as an “Expert User” of department database(s). Monitor department databases for continuous improvement opportunities. Maintain current knowledge of the FDA regulations (frequent reading of the trade press/emails, FDA news bulletins, attending job-related webinars, or outside courses when appropriate); consider innovative solutions to meet changing regulatory compliance goals. Provide support to internal and external customers regarding complaints or other post market activities as needed. Provide assistance to bring resolution to complex cross functional issues. Requirements: BS Degree, engineering or science degree highly preferred. RAC or ASQ certifications a plus. Strict attention to detail. Must be able to work in an open office environment. Must be able to work independently and prioritize with little supervision. Strong written and oral communication and interpersonal (listening) skills. Must have ability to lead efforts aimed at the identification of problematic situations, the reporting of issues, and the development of resolutions and decision making. Minimum 3 years experience in a regulated industry (medical device or pharmaceutical). Post market regulatory, quality or compliance areas preferred. Familiarity with basic quality tools and techniques. Analytical and Critical thinking skills are essential. Excellent organizational and time management skills. Proficient with complaint handling software, ERP systems, and Microsoft Windows applications. Ability to read and understand a Risk Analysis Report. Qualifications should be submitted to: Mike Coulter mcoulter@arstaf.com Location: West Chester, PA Compensation: Commensurate with Experience This is a contract job. Principals only. Recruiters, please don't contact this job poster. Please, no phone calls about this job! Please do not contact job poster about other services, products or commercial interests. delaware