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REGULATORY AFFAIRS CONSULTANT
Company:ICDS RECRUITMENT |
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Job Reference Number |
14566455 |
Client ID: |
RI/AM12503 |
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Posted On: |
Feb 7 2012 |
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Location: |
OFFALY |
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Job Type: |
Contract |
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Salary: |
NEGOTIABLE |
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Regulatory Affairs Consultant - County Offaly.
This position is being offered as a fixed term contract of 2 to 6 months.
This Scope of Work outlines the requirements for the completion of formal Regulatory File submittals for CE Marking in compliance with MDD, Product Safety Files, 510(k)s and support for Vigilance activities for global market, against an aggressive timeline.
Overview of deliverables:
Complete EU Class III Design Dossier review
Prepare EU Class III Design Dossier, and submit
Construction and submittal of CE TF
Update EU DofC via change control and ready same for approval
Review with Div RA and decide on ICP/O2 cable kits / cable items re CE certification updates
510(k) DT reviews for 60601 3rd Ed changes – there are many of these
Update of CE TFs for 60601 3rd Ed and Brand logo changes
Update of UL File for 60601 3rd Ed and Brand logo changes
Update of CSA File
RA oversight on DTs for complaints – MDR, MDV, TGA, TPP
Submittal of vigilance reports etc as required, along with support for submittals via other sites
Prepare and manage FSCA / Recall Files as may be applicable in the period
The RA Consultant shall provide the QA/RA Manager and the team with a regular progress status report for each of the deliverables.
Interested applicants should have a proven track record in Regulatory Affairs as relates to Medical Devices within global market regulatory scope.
