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 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
  • Email
  • Phone
  • Harish Yadav
  • harish.yadav@collabera.com
This Job is no longer accepting applications
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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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