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Job Field: Legal Jobs
Location: SALT LAKE CITY, UT
Job Type: Full Time

JOB SUMMARY:

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Regulatory Specialist II needed for a Salt Lake employer. Duties: The Regulatory Specialist II is responsible for executing all aspects of the supplier management and change management processes. The Regulatory Specialist II owns and coordinates CAPAs and complaints and also reviews and approves quality agreements. As the owner of medium and low risk regulatory processes, the Regulatory Specialist II is responsible for the complete systems of internal audits, external audits, change management and supplier management. The Regulatory Specialist II also participates in internal and external audits on a regular basis, supporting the audit-ready philosophy of the company. The Regulatory Specialist II acts as the deputy for the Regulatory Specialist I and contributes to other Regulatory Affairs processes as needed. Essential job functions: Supplier Management -Manage the Qualified Supplier List and perform annual assessments of suppliers -Assist with the qualification process for essential suppliers and subcontractors and perform on-site audits as needed Change Management -Review, approve and close requests -Perform risk assessments -Maintain documentation and files Corrective and Preventive Actions and Complaints -Coordinate, initiate, investigate and own corrective and preventive actions and complaints -Work with area managers to perform root cause analysis and develop action plans -Complete actions in a timely manner through all stages of processes -Ensure customer satisfaction during complaint resolution Quality Agreements -Review, negotiate and approve quality agreements Qualifications: High School Diploma or equivalent and four years quality experience OR A.S with three years quality experience OR B.S with two years quality experience. CQA or equivalent certification preferred. Hours are Monday - Friday 8/9AM to 4/5PM This position requires successful completion of a drug test and criminal background check. Equal Opportunity Employer.

KEY REQUIREMENTS:

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