Sr Regulatory Affairs Specialist

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Sr Regulatory Affairs Specialist

  • Specialty:

    Engineering
  • Title:

    Sr Regulatory Affairs Specialist
    • City:

      West Chester
    • State:

      PA
    • Zip Code:

      19380
  • Start date:

    02-08-2018
  • Status:

    Closed
  • Assignment Type:

    Contract
  • Job Id:

    44565

Description

Our client located in West Chester, PA is looking for a Sr Regulatory Affairs Specialist to  join their team on a contract basis.

 

The Sr Regulatory Affairs Specialist will be responsible for:  

  • Working alongside the Product Development Teams and be responsible for integrating multiple sites and push regulatory deliverables.
  • Participate in regulatory impact assessments as it relates to the MDR and relay the information to product specific RA team member and/or design teams.
  • Filing MDR’s for OUS.
  • Assure collection of appropriate data for MDR regulatory submissions and compliance.
  • Complete gap assessments on Technical Files.
  • Update OUS registrations and creating new registrations

 

REQUIREMENTS:

  • Minimum of a Bachelor's degree and 5 years of experience in Regulatory Affairs
  • Experience with MDR/Vigilance
  • Experience updated and creating OUS registrations
  • Complete Remediation on Tech Files

#MON  #marle-b

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