Compliance Engineer (Regulatory Operations)

Contract: Santa Clara, California, US

Salary Range: 50.00 - 52.00 | Per Hour

Job Code: 358023

End Date: 2025-02-22

Job Status: Expired

This Job is no longer accepting applications

Role Overview:

  • Provide compliance support to the Regulatory Affairs (RA) team by:
  • Creating KPI dashboards and monitoring RA management reviews and metrics.
  • Managing RA audit preparedness, including risk identification and mitigation.
  • Supporting quality system integration for acquisitions and new products.
  • Identifying and implementing systemic process improvements.
  • Tracking and maintaining regulatory post-approval commitments.
  • Driving quality system process improvements.

Key Initiatives:

  1. Establish audit support for integration products.
  2. Enhance and maintain quality system procedures.
  3. Collaborate with cross-functional and international teams for audit compliance.
  4. Participate in audit backrooms and RA projects.

Core Tasks:

  • Track and close RA change requests.
  • Manage change processes.
  • Develop and implement audit plans for critical RA tasks.
  • Manage CAPAs and audit findings.
  • Oversee post-approval commitments.
  • Support RA perspective in QMS audits and integration tasks.
  • Present management review metrics results.

Required:

  • BS requird.
  • 5-7 year of experience required.

Pay Range:

  • $50-52/Hr

 

Job Requirement
  • CAPAs
  • audit
  • QMS
  • quality system
  • Regulatory Affairs
  • RA audit
  • Veeva
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Sanjay Rawat
  • sanjay.rawat@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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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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