Regulatory Affairs Operations Specialist - Vascular (on-site)

Abbott seeks a Regulatory Affairs Operations Specialist for its Vascular division in Temecula, California. The role focuses on maintaining quality systems and compliance initiatives, managing audit readiness programs, and ensuring alignment with evolving regulatory requirements across multiple device families.

Responsibilities

• Assess and communicate impacts of new regulations on quality systems, submissions, and operational practices
• Manage audit readiness program execution including pre-audit preparation, resource management, and risk mitigation
• Serve as subject matter expert for international addendum labeling requirements and controls
• Investigate nonconformities, determine mitigations, and develop corrective action plans
• Support cross-functional teams and maintain current processes aligned with regulatory changes

Requirements

• Bachelor's degree in scientific discipline, engineering, or medical fields
• 2-3 years experience in regulated industry (medical devices, pharmaceuticals, nutritionals preferred)
• Team collaboration and fast-paced matrixed environment capability
• Strong verbal and written communication across organizational levels
• Knowledge of FDA and international regulatory requirements