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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:
- Establish audit support for integration products.
- Enhance and maintain quality system procedures.
- Collaborate with cross-functional and international teams for audit compliance.
- 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
- Phone
- Sanjay Rawat
- sanjay.rawat@collabera.com
This Job is no longer accepting applications
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