Company DescriptionKatalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.Job DescriptionEssential Duties and Responsibilities:Good understanding of product lifecycle, BOM structuring, standardization, Change management process.Lead data collection for over 400 Class II product codes for FDA GUDID Submission in 2016Lead data collection for over 250 Class II-LS product codes for FDA GUDID Submission in 2015Must have good knowledge on Medical products labeling & its standards.Should have hands on experience in UDI & GUDID.Create and review procedures (SOPs) for data collection, review, updates, change control, training documents, and discontinuationCollaborate on creating and maintaining project plans, deliverables, PLM data, status reports, and other project related activitiesManage the day-to-day activities for a total of 4 engineers to complete project deliverablesGood in documentation process, engineering documentation and specification standardization.Strong analytical skills with the ability to collect, organize, analyze Design related data from varies specification documents.Ability to understand large structured and unstructured data with attention to Design parameters from various products.Demonstrated superior communication (written and verbal), teamwork, and organizational skills.Experience in PLM tools – ERP, Teamcenter, SAP and any other PLM Tools.Excellent skills in MS Office (Word, Excel & PowerPoint) and MS Access tool.Highly proficient in configuration management.Maintain and own internal documents.Write, revise and review SOP'sAdditional InformationAll your information will be kept confidential according to EEO guidelines.