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Regulatory Specialist

Company: HCL Technologies
Location: Warsaw
Posted on: June 24, 2022

Job Description:

Resource to be aware/understand the Regulatory activities such as BSI approval process, 510K approval process, CE marking & etc.Should have good knowledge in legacy ERPs systems such as AS400 & ERPs terminologies.Understand the process better and exploring the new execution ways by interacting with the SMEs directlyBased on input from Regulatory, To Maintain Notified Body Number, Technical File, CE Mark, and Design Dossier (BSI) Approved values in the AS400/DePuy PRMS as needed with the help of completed PRMS Technical File Master Update Request (Attachment A)Communication Skills, Customer handling & Problem SolvingHands-on experience in ERP system with respect to RegulatoryShould have Minimum 5 + Years of experience in Regulatory & ERP systemWilling to work in data maintenance activities in ERPsIndependently handle the project with minimal support System and Tools:AS400 / PRMSRAD

Keywords: HCL Technologies, South Bend , Regulatory Specialist, Other , Warsaw, Indiana

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