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Regulatory Affairs Associate

3 months ago

Lake Forest, Illinois, United States Collabera Full time
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Job Description

Regulatory Affairs Associate

Contract:
Lake Forest, Illinois, US

Salary:
$30.00 Per Hour

Job Code: 347263

End Date:
Days Left: 26 days, 3 hours left

Apply

To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - ), email your updated resume at Email - or give me a call at 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
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Email
Phone
Chitrank Rastogi

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