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Compliance Associate

Compliance Associate


Requirements:?



  • Bachelor?s degree required.?

  • 1-3 years of experience working in a Quality related field; experience in a Medical Device environment preferred.??

  • Proficiency in Microsoft Office programs including Word, Outlook, PowerPoint, and Visio required.?

  • Advanced Excel skills required.?

  • Knowledge of Microsoft Project and OneNote optional.?

  • Proficiency in Enovia required.?

  • Foundational understanding in recall processes, including knowledge of 21 CFR Part 803, 806 and 820.3, ISO 13485:2003, MEDDEV 2.12.1, European MDD, Japan Pharmaceutical Affairs Law (JPAL) and Health Canada regulations.?
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Preferences:?



  • 3-5 years of experience with SAP reporting preferred.?

  • 1-3 years of experience with SharePoint preferred.?

  • Working knowledge of SalesForce ServiceMax preferred.?

  • Prior training experience preferred.


DEPARTMENT/TEAM DESCRIPTION?
The Issue and Complaint Management group handles FDA/Regulatory Body requirements for Radiology. The group handles all complaints, submits MDRs as applicable, and handles Field Actions and Material holds, as well as Supply Chain Quality activities. In addition, the group is responsible for Post Market and pre-market safety assessments.?
POSITION SUMMARY?
The purpose of the Compliance Associate is to manage, coordinate, administer, and maintain Radiology?s Vigilance System as it relates to recalls, field corrective actions, and material holds to ensure compliance with worldwide regulations. Challenges include maintaining current knowledge of Radiology product lines and processes as well as the changing regulatory, business, and market environments. The position must balance compliance issues with the company?s competitive position. The position is also responsible for data analysis and ad hoc reporting related to all aspects of Commercial Quality and Supply Chain Quality. The Compliance Associate will assist with all aspects of situation analyses, product recalls, field corrections, and material holds. .?
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Responsibilities:?



  • Responsible for administering and managing all product recall/field correction activity to closure.?

  • Responsible for administering, reconciling, and managing all material hold activity to closure.?

  • Responsible for managing communications and recall initiation with International regions for all product recall/field correction activity.?

  • Responsible for drafting notifications to health authorities and notified bodies including but not limited to: FDA, Health Canada, BSI, etc.?

  • Responsible for revising departmental policies and procedures in Enovia to continually improve Radiology?s compliance programs.?

  • Maintains Situation Analysis (SA) log, composes and distributes PQSC (Product Quality Safety Committee) meeting minutes, and tracks PQSC Action Items to completion.?


Location: Indianola, PA


Duration: 1 year


 

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