Regulatory Affairs Specialist in Des Plaines, IL

  • Title: Regulatory Affairs Specialist
  • Code: RCI-34796
  • RequirementID: 116766
  • Location: Des Plaines, IL 60018
  • Posted Date: 04/02/2024
  • Duration: 8 Months
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  Job Description

Education:

  • BA Degree Required

Years Experience:

  • Must have 1-2 years of experiences in Medical Device Reg Affairs

Skills:

  • Have working knowledge in EU MDR Have working knowledge in Regulatory Change Assessments
  • Have working knowledge in US and EU medical device submissions
  • Work cross-functionally and in a matrixed environment Have experience with continuous improvement activities

Duties:.

  • Assist the strategy implementation and operations for regulatory affairs activities, including preparing documents and deliverables to supporting change notifications and submission activities , license renewals etc.
  • Working knowledge of the regulations including EU MDR would be helpful in understanding the regulatory requirements for IVDR implementation.
  • Identify opportunity for regulatory affair processes and drive changes to completion.
  • This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
  • Additionally Provide tracking, reporting, and presentation to management for the project activities.


About Rangam:

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