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Regulatory Affairs Associate - Exp

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Yingying Lin

Mahwah, NJ

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Job Location(s)US-NJ-MahwahPosted Date1 day ago(1/10/2018 9:32 AM)Job ID2018-28698CategoryMedical ServicesPosition TypeContract (Full-Time)# of Openings1Overview*Regulatory Affairs Data Steward** ** PLEASE INCLUDE POWER USER EXCEL SCORES TO EVERY SUBMITTAL ** Responsibilities• Manage and implement data for UDI compliance for all divisional product lines. • The ability to understand and gain expertise in multiple processing systems. • Review source system to determine accuracy, audit data for discrepancies, correct errors where appropriate. • Input information in pre-described formats; verifying data entry ensuring accuracy and completeness of information • Updates records to include deleting, changing or additions to Regulatory Affairs data files • Produces database summaries and reports/data extracts as requested. • Evaluate processes for gaps, inefficiencies and additional opportunities and provide suggestions for improvement • Performs related duties as requiredQualifications• Strong MS Office suite skills (Excel, Word, PowerPoint, Project) and preferable working knowledge of Oracle • 1-2 years of data collection, mining, reporting and process analysis • Well organized, detail-oriented, proactive, resourceful and efficient with strong analytic skills • Strong interpersonal skills; ability to work with all levels of internal management • Experience in a fast paced, high volume, process oriented environment • Experience in FDA regulated industry • Working knowledge of FDA Medical Device Regulations is a plusWe can recommend jobs specifically for you!Click here to get started.

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Yingying Lin

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