Quality and Regulatory Specialist I - Hybrid - Remote

Overview

The Quality and Regulatory Specialist is responsible for ensuring compliance with quality standards and federal regulations while maintaining knowledge of industry guidelines and company procedures.

In Short

• Review protocols, informed consents, and case report forms prior to study initiation.
• Ensure company policies meet regulatory standards.
• Collaborate with operational teams for regulatory compliance.
• Prepare and submit documentation to regulatory agencies.
• Stay updated with changes in regulatory legislation.
• Monitor and set standards for quality control.
• Conduct internal audits for adherence to QA standards.
• Train staff on quality and compliance issues.
• Address non-compliance issues.
• Assist with clinical study protocol deviations.

Requirements

• Associates degree with 2-4 years of relevant experience or Bachelor's degree with 1-3 years of relevant experience.
• Ability to understand clinical studies and regulatory requirements.
• Excellent organizational and interpersonal skills.
• Knowledge of GCP ICH/GLP guidelines and Federal Regulations.
• ISO 19011 Internal Auditing Training is preferred.

Benefits

• Hybrid work arrangement with three days on-site and two days remote.
• Equal Opportunity Employer.
• Support for individuals with disabilities during the application process.