Regulatory Operations Lead, Vascular Devices

Abbott; Temecula (CA); On-site; USD 61,000 - 123,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Retirement plan

Education benefits

Job summary

Abbott Vascular is recruiting for a Regulatory Affairs Operations Specialist to join our Temecula, CA on-site team. You will support quality systems, conformance, and audit readiness, coordinating with internal and external stakeholders to ensure regulatory compliance across multiple therapies and devices.

The role emphasizes managing audits, maintaining documentation, and guiding cross-functional teams through regulatory changes within a dynamic landscape.

Qualifications

• Bachelor’s degree in scientific discipline, engineering, or medical fields.
• 2–3 years’ experience in a regulated industry (medical products, nutritionals, pharmaceuticals).
• Strong verbal and written communications across multiple levels in the organization.

Responsibilities

• Assess and communicate impacts of evolving regulations on quality system processes and regulatory operations.
• Serve as SME for International Addendum Labeling requirements and controls across departments.
• Manage execution of the Audit Readiness Program for Regulatory Affairs including requests, KPI management, and risk mitigation.
• Maintain key pre-audit requests and disseminate audit activities to stakeholders.
• Assist in development of quality system conformance strategy and update strategy based on emerging issues.

Skills

Teamwork

Communication

Regulatory knowledge

Education

Bachelor’s degree

Job description

Abbott Vascular is recruiting for a Regulatory Affairs Operations Specialist to join our Temecula, CA on-site team. You will support quality systems, conformance, and audit readiness, coordinating with internal and external stakeholders to ensure regulatory compliance across multiple therapies and devices.

The role emphasizes managing audits, maintaining documentation, and guiding cross-functional teams through regulatory changes within a dynamic landscape.