Senior Regulatory Compliance Specialist

Abbott • Lake Forest, CA

12h • $85,300 - $170,700 • Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. Our diagnostic division is looking for a Senior Regulatory Compliance Specialist based out of our Lake Forest, IL office. This individual will provide compliance oversight and guidance for quality systems, quality subsystems and/or key processes. Incumbent manages compliance activities and assessing impact and/or implementation of new or changing regulations to quality systems for Division, manufacturing sites and/or affiliates. Facilitate and coordinate inspection/audit readiness activities and communicates progress updates and opportunities for improvements to management as applicable and provides compliance direction for audit action plans. The incumbent will report to the Manager, Quality Systems Regulatory Compliance. It is expected that this individual will interact frequently with Division management and therefore requires a high level of competence, confidence and credibility.

Requirements

• Bachelor’s degree in Life Science, Engineering, or closely related discipline
• Minimum 5 years work experience in Quality, Regulatory or related experience
• Experience in the health care industry.
• Has a history of completing successful cross-functional projects and driving positive compliance outcomes.
• Demonstrates good; general understanding of the standards and regulatory bodies that regulate our industry.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Lead projects to support Divisional scope; multi-site quality system projects with cross-functional and represent own team while on cross-functional project teams with other functional leaders.
• Supports achieving Division goals and strategic initiatives.
• Communicates confidently and effectively with management, peers and key stakeholders, ensuring successful compliance status of the Division, manufacturing sites and/or affiliates.
• Interprets regulations and requirements and supports implementation of program and procedures to meet requirements worldwide.
• Defines project goals and milestones.
• Responsible for timely project completion.
• Provide solutions to a wide range of difficult problems.
• Ensures solutions are compliant; innovative; thorough; practical and consistent with organizational objectives.
• May leads projects with cross-functional broader scope.
• Represents team on cross-functional projects with other functional leaders.
• Directly influences project direction and scope.
• Implements tactical solutions related to assignment.
• Able to contribute functional skills and expertise broadly.
• Communicates confidently and effectively with management, peers, and key stakeholders.
• Contributes functional skills and expertise broadly.
• Scope includes one or more QA functions with general knowledge of other related disciplines.
• Provides guidance and trains other Professionals and Technicians.
• Ensures compliance to Division and Corporate policies and procedures.
• Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.

Benefits

• 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees