Regulatory Operations Specialist-Quality & Audit Readiness

Abbott (abbottcareers2 board); United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Abbott in Temecula, CA is seeking a Regulatory Affairs Operations Specialist to join Abbott Vascular on-site. This role partners with internal and external stakeholders to maintain the quality system and ensure compliance with evolving regulatory requirements.

You will manage the Audit Readiness Program, International Addendum Labeling controls, CAPAs, change control, and cross-functional project work to support regulatory operations across therapies and devices.

Responsibilities

• Assess and communicate impacts of evolving new regulations on internal quality system processes and regulatory operations
• Serve as a subject matter expert for International Addendum Labeling requirements and controls, partnering with Shared Services, International Regulatory Affairs, Labeling, Commercial Quality, and Regulatory Affairs
• Manage execution of the Audit Readiness Program for Regulatory Affairs including preparation of pre-audit requests and in-audit requests, audit resource management, audit calendar and KPI management, and audit risk mitigation activities such as audit near misses / opportunities to closure
• Maintain key pre-audit requests up to date throughout the year and ensure that key audit activities are disseminated to appropriate personnel
• Support a audit backrooms, or front rooms as applicable
• Prepare and / or review Regulatory Affairs formal management review and internal metrics content
• Maintain processes and SOPs current, in alignment with new regulatory requirements. Creates, reviews, and processes, including approving change orders in the applicable document control systems
• Assist in the development of quality system conformance strategy and update strategy based upon Emerging Issues/ Regulatory Intelligence
• Acts as a regulatory operations representative on cross-functional project teams and task forces, communicates regulatory requirements and impact of regulations to the functional team(s). Provides guidance and expertise
• Investigate nonconformities and determine mitigations, resolution plan (CAPA)
• Delivers on project timelines to achieve departmental and organizational objectives
• Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, proce

Job description

Abbott in Temecula, CA is seeking a Regulatory Affairs Operations Specialist to join Abbott Vascular on-site. This role partners with internal and external stakeholders to maintain the quality system and ensure compliance with evolving regulatory requirements.

You will manage the Audit Readiness Program, International Addendum Labeling controls, CAPAs, change control, and cross-functional project work to support regulatory operations across therapies and devices.