Principal Regulatory Compliance Specialist

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.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are 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.

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.
  
  

The Opportunity

Our location at Lake Forest, IL is looking for a Principal Regulatory Compliance Specialist. This person will be responsible in working with a global team of Quality Specialists to ensure

effectiveness to the Core Dx Quality System and Key Processes and support continuous improvement projects and metrics to ensure compliance with regulatory requirements. They will be responsible for designing and maintaining programs for the

systematic monitoring and evaluation of the various aspects of the quality system to ensure that standards of quality are being met as well as continuously improved upon.

What You’ll Work On

• Responsible for application of quality principles, complex analysis of quality records and quality data to provide metrics and reports.
• Manage and execute projects to ensure continuous improvement.
• Responsible for conducting quality-related activities to deliver consistent; high quality documents; services; products and processes.
• Conduct inspection and verification of data and calculations used in quality system monitoring.
• Identify and address recurring problems, provide solutions, and manage process improvements.
• Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
• Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
• Monitors compliance with company policies and procedures (e.g., compliance with FDA, BSI, EEO regulations etc).
• Participates in internal and external audits and inspections.
• Translates department goals into individual objectives and KPIs.
• Identifies, develops, and implements processes to improve department performance.
• Monitors division activities and records to ensure compliance independent action through critical, data-driven decision making.
• Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by executing project work for maintaining quality system capability.
• Ensures compliance to Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
• Align goals to department success factors, understand the business strategy of the
• organization.
  
  

Required Qualifications

• Bachelor's degree required and or direct experience.
• Minimum 9 years of experience in quality or related experience
  
  

Preferred Qualifications

• Comprehensive knowledge of the Abbott Quality System.
• CAPA experience.
• 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.
• Demonstrates good knowledge of regulations and standards affecting IVDs and Biologics.
• Has a history of completing successful projects and driving positive compliance
• outcomes.
• Experience with external inspections e.g., FDA, Notified Bodies.
• Data Visualization & Dashboard building skills, e.g., Power BI, Smartsheet.
• Experience working with Abbott product or quality data, with intermediate to Expert
  
  

level Excel.

• 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.
  
  

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted.