Regulatory Affairs Operations Specialist - Vascular (on-site)

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

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

The Opportunity

We are recruiting for a Regulatory Affairs Operations Specialist to join our Abbott Vascular team on-site in Temecula, CA. This is a unique role where you will partner with external and internal stakeholders to maintain the quality system current and effective in alignment with the dynamic regulatory landscape and new/evolving requirements.

The position is within the Regulatory Affairs Operations organization rather than direct regulatory submission preparation; this role involves supporting Quality System and Compliance initiatives such as Audit Readiness Program Management, including coordination of audit requests, Emerging Regulatory Issues and implementation of conformance, needs involving multiple therapies or device families, Quality System processes, Change Management, CAPAs, International Addendum Labeling controls, Management Review Metrics, etc.

What You'll Work On

• Assess and communicate impacts of evolving new regulations on internal quality system processes, regulatory submissions, and regulatory operational practices; ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• 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 to ensure requirements are reflected within the quality system, and business compliance with country-specific requirements.
• 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, audit storyboards for critical topics; partner with Regulatory Compliance, Regulatory Affairs, Quality, Shared Services as needed for audits.
• 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