Regulatory Business Systems Analyst

Job Summary

A company is looking for a Regulatory Business Systems Analyst to serve as a liaison between business units and technical support personnel.

Key Responsibilities

• Ensure compliance with cGMP, FDA, OSHA, and other regulatory requirements while maintaining knowledge of SOPs and current practices
• Collaborate with stakeholders to gather requirements and identify process improvement opportunities
• Manage user access and perform audits to maintain the validated state of regulated software

Required Qualifications

• High school diploma or GED is required
• A minimum of 3 years of Business/Technical analyst experience in an FDA regulated environment
• A minimum of 1-3 years of experience in validating computer systems
• Knowledge of software validation for regulated software
• Experience with application support and familiarity with Quality Management processes preferred