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Regulatory Assistant

Integrated Resources, Inc Plainsboro Township Contractor
$58,504.00 (Careerbuilder est.)
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Joib title: Regulatory Assistant Duration 4 mos. Shift Mon. Fri. 9am-5pm Job Description
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
  • Review various regulatory filings, products, labels, IFUs and information systems to identify and collect the relevant approval data and documents required for CLIENT's regulatory information systems
  • Assist with research activities to obtain missing or partial information and resolve inconsistent information
  • Read and use information from existing regulatory documents and information systems to identify and list the SKU(s) covered by a single regulatory approval
  • Analyze data across multiple information systems, identify discrepancies and coordinate with regulatory leads for the impacted product lines or regions to resolve any data discrepancies
  • Coordinate with regulatory leads to approve and lock data after it has been verified
  • Track progress of data collection, verification and closure
  • Maintain and update regulatory data and documents throughout their lifecycle and as product changes are implemented
  • Assist with documenting processes and procedures for the collection, verification, control, and maintenance of approval data and documents
  • Participate in project team meetings and be accountable for assigned tasks
  • Contribute to the CLIENT regulatory department effort and other regulatory information needs as required
The requirements listed below are representative of the knowledge, skills, and/or abilities required for this position.
  • High School Diploma or Associate Degree; Bachelor's Degree preferred
  • 1 - 2 years relevant experience in data governance, management or analysis
  • Basic knowledge of medical device regulations preferred
  • Familiar with enterprise software management tools such as Oracle and Agile PLM preferred
  • Must be detail-oriented, proactive, adaptable and a fast learner
  • Excellent organizational, teamwork, and collaboration skills
  • Demonstrated ability to acknowledge issues or problems and work quickly to identify solutions
  • Basic to intermediate skill in data analysis using Microsoft Excel or similar software
  • Basic skill with common software applications including Microsoft Word, Outlook, PowerPoint, Visio and Adobe Acrobat

 

Recommended skills

Microsoft Power Point
Microsoft Word
Data Analysis
Microsoft Outlook
Analysis
Software Applications

Location

CareerBuilder Estimated Salary

This estimation is based on Job title, Industry, Location and Skills
$58,504
Avg. Yearly Salary

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Regulatory Assistant
$58,504.00 (Careerbuilder est.)
Estimated Salary: $70K
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Job ID: 19-16817

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