Regulatory Business Analyst

Job Summary

A company is looking for a Regulatory Business Analyst to ensure compliance and support quality systems in a regulated environment.

Key Responsibilities

• Ensure compliance with regulatory requirements and maintain knowledge of Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs)
• Assist in internal audits and inspections while leading compliance activities and conducting data integrity checks
• Build strong relationships with stakeholders to address software business process requirements impacting quality departments

Required Qualifications

• High school diploma or GED required
• Minimum of 3 years of Business/Technical analyst experience in an FDA regulated manufacturing environment
• 1-3 years of experience in validating computer systems required
• Familiarity with Quality Management processes and terminology preferred
• Experience with software development life cycle preferred