Regulatory Operations & Audit Readiness Specialist

Abbott; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Abbott Vascular in Temecula, CA is seeking a Regulatory Affairs Operations Specialist to join our team on-site. You will partner with internal and external stakeholders to maintain a current, effective quality system aligned with regulatory changes.

Your role focuses on Audit Readiness, conformance strategies, and governance across multiple therapies, ensuring compliance with FDA and international requirements while supporting Quality Management Systems.

Qualifications

• Experience in regulatory operations and quality systems management.
• Ability to coordinate audits and manage audit requests.
• Knowledge of international labeling and compliance requirements.

Responsibilities

• Assess impacts of evolving regulations on quality systems and regulatory submissions.
• Serve as SME for International Addendum Labeling requirements.
• Manage Audit Readiness Program including KPI management and audit calendars.
• Prepare pre-audit and in-audit requests and track remediation (CAPA).
• Maintain up-to-date pre-audit requests and disseminate audit results.
• Support regulatory backrooms/front rooms as applicable.
• Maintain processes and SOPs current with new regulatory requirements.
• Lead cross-functional project teams on regulatory topics.
• Investigate nonconformities and determine mitigations (CAPA).

Skills

Regulatory operations

Audit readiness

Quality management

CAPA

Change management

Regulatory compliance

Cross-functional collaboration

Documentation control

Tools

Document control systems

Job description

Abbott Vascular in Temecula, CA is seeking a Regulatory Affairs Operations Specialist to join our team on-site. You will partner with internal and external stakeholders to maintain a current, effective quality system aligned with regulatory changes.

Your role focuses on Audit Readiness, conformance strategies, and governance across multiple therapies, ensuring compliance with FDA and international requirements while supporting Quality Management Systems.