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Regulatory Affairs Data Steward

Job Category:
Technology Provider
Career Level:
Mid Career (2+ years of experience)
Job Type:
Contractual
Positions:
1
Company Name:
Joule
City:
Mahwah
Country:
USA
Description:

Type: Contract

Category: Scientific & Clinical

Job ID: 117327

Date Posted: 05/12/2017

 

Our medical device client in NJ is currently hiring   Please apply ASAP for more information.  

Job Title: Regulatory Affairs Data Steward

Location: Mahwah, NJ

Duration: 6 months 

Requirements:

-1-2 years of data collection, mining, reporting and process analysis

-Experience in FDA regulated industry

-Ability to understand and gain expertise in multiple processing systems. 

-Working knowledge of FDA Medical Device Regulations is a plus

Responsibilities:

-Compile and Manage product registration data for all divisional product lines. 
-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