divh2Compliance Specialist/h2pIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing./ph3Job Description/h3pJob Title: Compliance Specialist/ppLocation: Louisville, CO Duration: 6+ months (possibility of extension) ESSENTIAL DUTIES AND RESPONSIBILITIES:/pulliThis individual will review, evaluate, and investigate product complaints relative to the identity, quality, reliability, safety, and effectiveness of Healthcare products./liliThe Analyst will provide technical expertise and assistance in handling/categorizing complaints to comply with current FDA and international reporting regulations./liliDuties also include compliance tracking, trend analysis and reporting to Management./liliThis individual must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective./li/ulpJOB QUALIFICATIONS:/pulliEvaluates incoming complaint information and maintains it in the electronic database./liliDetermines reportability (MDR/AE) of complaints to FDA and other international regulatory agencies./liliWorks closely with customers and sales representatives to respond to complaint reports./liliClosely monitors quality, completeness and timeliness of complaint investigations and files./liliReviews, tracks, trends, analyzes and reports on complaint data to Management and other departments as needed./liliWorks with cross functional teams to ensure proper communication and evaluation/investigation of customer issues./liliParticipates in team decision making and displays team problem solving/communication skills./liliPrepares and presents information in meetings and to upper Management/liliMay serve a team member on projects/programs./liliMay provide guidance and training to support staff and new analysts./liliMay visit customer sites to meet with staff to discuss complaint issues./liliMay take lead on specific complaint issues and coordinate with other departments to further investigate./liliMay create/ or be responsible for revision of procedures/processes/liliAd hoc reporting./liliComplies with all health, safety and environmental policies./li/ulpPREFERRED SKILLS/QUALIFICATIONS :/ppRegulatory and Quality Management skills/ppSKILLS/COMPETENCIES :/pulliCustomer service, Data analysis; Basic understandings of industry practices and standards; Other Skills: MS Office, Written and verbal communication;/li/ulpEDUCATION:/pulliBS in clinical/medical, Engineering or science/li/ulpORGANIZATIONAL RELATIONSHIPS/SCOPE:/pulliReports to Senior Analyst/Supervisor/Manager position as applicable./liliWorks closely with other local QA, International RA/QA, Sales, Marketing, Customer Service, RD, Manufacturing, Engineering, Clinicals and Legal departments./li/ulpWORKING ENVIRONMENT/PHYSICAL ACTIVITIES :/pulliUsual Office environment with frequent Sitting, walking, standing, kneeling, crouching, crawling, balancing, stooping and occasional Climbing./liliFrequent use of eye, hand and finger coordination enabling use of Office machinery./liliOral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone./liliLight physical effort required by handling objects up to 20 pounds occasionally* and/or up to 10 pounds frequently./lili*Occasional: Activity exists less than 1/3 of the time./liliFrequent: Activity exists between 1/3 and 2/3 of the time./li/ul/div