Senior Analyst, RAQA Compliance - Individual Contributor

Job Title: Regulatory Affairs Specialist
Location: Remote
Hours/Schedule: Monday-Friday, 8:00 am - 5:00 pm
Type: Contract
Overview
The Regulatory Affairs Specialist supports regulatory compliance activities by preparing assessments and submissions required for product clearances and approvals. This role serves as a regulatory resource to project teams, ensuring regulatory requirements are understood and executed accurately across FDA and other regulatory bodies. The position requires independent work with appropriate collaboration on complex or unusual matters.
Responsibilities

• Prepare and manage regulatory assessments, documentation, and submissions to FDA, Notified Bodies, and other regulatory authorities.
• Apply regulatory and legal frameworks, requirements, and procedures to support product clearances and approvals.
• Coordinate and execute regulatory deliverables, including writing, project tracking, and cross-functional alignment.
• Complete technical and scientific regulatory assignments that support product development and compliance objectives.
• Provide regulatory guidance to project teams as a subject matter resource.
• Communicate status, risks, and outcomes to supervisors and senior regulatory staff as appropriate.
• Exercise independent judgment on routine regulatory matters and escalate complex issues when needed.

Qualifications

• Bachelor's degree (B.S. or B.A.) in Engineering, Science, or a related field.
• 2-3 years of experience in an FDA-regulated industry.
• Working knowledge of regulatory requirements and submission processes.
• Ability to manage regulatory tasks independently with minimal supervision.
• RAC certification or a master's degree in Regulatory Affairs preferred.

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #568-Clinical