Clinical Data Analyst

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-state area's most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since 1996. Our mission is to deliver top-quality talent, the first time and every time. We provide resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy, and Nursing. Job Description Duration: 12 Months + Contract Summary of Position: Required Competencies: Experience in technical and clinical data review . Attention to detail and problem-solving skills. Excellent verbal, written, and presentation skills. Ability to work independently. Desired Competencies: Working knowledge of EU IVD regulations . Working knowledge of IVD products and regulations . Familiarity with web-based content sharing applications (e.g., SharePoint), Microsoft Office Suite, Adobe. Responsibilities Assess client’s products based on classification, identify gaps against the Technical Documentation (Annex II - 2017/746), and determine resources needed for addressing gaps for budget planning. Create draft Performance Evaluation reports for a sample of Class B, C, and D products. Suggest opportunities to fill gaps with data from sources like published literature or post-market data. Provide periodic updates to the IVDr Project Lead as scheduled. Comments/Special Instructions Knowledge of EU IVD Regulations is a plus. Qualifications 5+ years of experience in a regulated healthcare industry, preferably in Medical Device/IVD. Experience in R&D or Clinical Affairs roles is preferred. Additional Information Feel free to share this opportunity with colleagues. Referral bonuses are provided. Thanks, Warm Regards, Nisha Integrated Resources, Inc. Specializing in IT, Rehab, Clinical, Nursing #J-18808-Ljbffr