Quality & Regulatory Compliance Specialist (Contractor) - Remote

Overview

The Quality & Regulatory Compliance Specialist (Contractor) will provide independent support to maintain and enhance the company’s Quality Management System (QMS) and ensure alignment with ISO standards and applicable FDA regulations.

In Short

• Independent contractor role focusing on quality and regulatory compliance.
• Maintain and support the company's ISO Quality Management System.
• Manage document control systems and quality records.
• Conduct internal quality audits and support external audits.
• Track and document Corrective and Preventive Actions (CAPA).
• Assist with regulatory documentation and compliance support.
• Collaborate with teams to ensure quality standards are met.
• Provide guidance and training on quality systems.
• Recommend continuous improvement initiatives.
• Work primarily remote with occasional on-site support.

Requirements

• Bachelor’s degree in Quality, Engineering, Regulatory Affairs, or related field preferred.
• 3–5+ years of experience in ISO quality systems or FDA-regulated environments.
• Experience with ISO Quality Management Systems and FDA compliance.
• Strong organizational and audit readiness skills.
• Ability to work independently with minimal supervision.
• Strong communication skills to interface with teams.

Benefits

• Flexible project-based schedule.
• Remote work with occasional on-site requirements.
• Ongoing contract engagement as needed.
• Opportunity to work in a dynamic environment.
• Independence in managing deliverables.