Regulatory Affairs Associate

Contract: Lake Forest, Illinois, US

Salary: $30.00 Per Hour

Job Code: 347263

End Date: 2024-05-19

Days Left: 15 days, 19 hours left

To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!


Job Description:
Job Roles & Responsibilities:

  • The role is to support the transition of our Alinity and ARCHITECT Clinical Chemistry and Immunoassay products to CE marking under IVDR, plus supporting changes and country requests.
  • This involves reviewing and approving the technical file chapters used in the submissions to the European notified body.
  • Sending notifications to countries to inform of changes following IVDR transition and completing the implementation.
  • Attending meetings to provide the product status and functional area input.

Top 5 skills/requirements HM would like to see:

  • Good communication skills, organised, able to cope with changing timelines and priorities, attention to detail, a knowledge of the IVDR Confirm interview preferences : video (two rounds, if applicable)
Job Requirement
  • Regulatory Affairs Associate
  • Regulatory Affairs
  • Alinity
  • ARCHITECT Clinical Chemistry
  • Immunoassay
  • IVDR
  • EU MDR
  • Medical Device
  • in vitro diagnostics
  • in vitro diagnostics
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Chitrank Rastogi
  • chitrank.rastogi@collabera.com
  • 4255231648
Apply Now
Apply Now
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