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Regulatory Affairs Project Leader
Contract: Santa Clara, California, US
Salary Range: 54.00 - 58.00 | Per Hour
Job Code: 350626
End Date: 2024-07-12
Job Status: Expired
This Job is no longer accepting applications
Pay range: $54 to $58/hr. (Negotiable)
Description:
• The candidate will assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system.
• The candidate will assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system.
• The position requires that they develop an understanding of the Clip products and manufacturing processes in order to review and assess proposed product changes within the change management system (in Change Orders and Change Requests).
Specific responsibilities will include:
• RA Lead / Core Team Support for manufacturing-related submissions
• RA Lead / Core Team regulatory support for international submissions and renewals
• Provide regulatory support for change management activities, including RA impact assessments in Change Requests, Submissions, and approval of change orders to implement approved changes.
• Review and approval of product release process and addendum labeling
• RA project team member for new quality system process changes and updates
Job Requirement
- Regulatory Affairs
- Medical Device
- MDR
- regulatory submissions
- Change management
- labeling
- Change Requests
- Change Orders
Reach Out to a Recruiter
- Recruiter
- Phone
- Harish Yadav
- harish.yadav@collabera.com
This Job is no longer accepting applications
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