Senior Compliance Auditor I

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 115,000 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 family, be your true self and live a full life. You will 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 This position works out of our corporate Abbott Park, Illinois location, or other applicable Abbott location. The Abbott Quality and Regulatory (AQR) Global compliance audit function is a corporate program which conducts audits of Quality Systems across all of Abbotts Manufacturing sites. Product quality and/or regulatory problems can negatively affect consumer health and safety, Abbott's worldwide image, performance of Abbott earnings and market share and customer confidence and loyalty. The role has a broad responsibility that has significant impact throughout AQR and all divisions. The position is responsible for ensuring executive management is aware of compliance business risks and regulatory requirements. We are seeking an experienced Senior Compliance Auditor with demonstrated expertise in auditing medical devices and in vitro diagnostics, including design and development controls, to ensure the protection of patient safety and compliance with applicable regulatory requirements, harmonised standards, and internal quality management system (QMS) procedures. The role involves conducting risk‑based audits across the full product lifecycle, with a strong focus on quality system effectiveness, risk management activities, and adherence to global standards and regulations including

ISO 13485, EU

MDR/IVDR, and FDA Quality System Regulation (21 CFR Part 820) requirements. As a Senior Compliance Auditor, you will lead Quality System audits and assessments according to regulations, standards, and Abbott procedures. You will participate in cross-divisional activities to integrate information from compliance audits, assessments and regulatory trends that may impact Divisions. The responsibility of the role includes proactive determination of regulatory, compliance, and quality issues, to integrate them into audits and assessments. This role requires highly effective communication and decision making with all levels of management as well as other division and corporate departments. The incumbent must be able to work independently without direct supervision or guidance and to exercise judgment in determining when complex issues merit Corporate Management involvement. Decisions must be made based on up-to-date regulatory knowledge, technical/business knowledge, and skills. What You will Work On Work independently to direct, plan, develop and implement audit policies and programs for systems division-wide. Lead in-depth risk-based Quality System audits across all Abbott manufacturing sites. Plan, execute, and report Abbott manufacturing site audits. Evaluate compliance with global regulations including

FDA 21 CFR

Part 11, FDA 21 CFR Part 820, ISO 13485, EU MDR/IVDR and other applicable regulations and standards. Monitor emerging regulatory requirements, industry trends and competitor analysis to develop audit strategies and identify products or process which require focused audits. Maintain up-to-date knowledge of evolving regulations and best practices in regulatory compliance. Review documentation, risk management files, and validation protocols for technical completeness and compliance. Identify non-conformities, product and process risks, and areas for improvement Write professional audit reports for executive management. Communicate effectively to articulate risks and associated impact to all levels of management. Develop and provide professional education on compliance and quality topics that are key to Abbott businesses. Develop risk-based audit program including development of Abbott wide auditor training and competency assessments. Analyze compliance risks and communicate trends and opportunities to senior leadership and corporate policy makers. Promote and apply best-practice analysis and auditing tools, understanding their constraints, advantages, and disadvantages, and ensuring adherence to established standards. Promote continuous learning and improvement within the audit team. The role involves up to 50% domestic and international travel. Required Qualifications Four-year degree in a scientific, technical or compliance discipline or equivalent experience Lead auditor certificate for Quality System audits is desirable. Required Skills In-depth knowledge of global standards and regulations including

ISO 13485, ISO 14971, FDA

QMSR, country specific requirements including UK, MDSAP, Health Canada, Australian TGA and China, and Japan PMDA. Strong analytical and problem-solving skills with attention to detail. Highly effective oral and written communication, critical thinking, and decision-making skills. Ability to manage multiple audits and prioritize effectively. Proficiency in audit tools and techniques; certifications such as ISO Lead Auditor are desirable. Effective time management skills Preferred Experience 7+ years in the medical device industry Proven history working on risk-based design including: Design planning and governance Integration of risk management throughout the design and product lifecycle Traceability across: User needs Design inputs Design outputs Verification & validation Design reviews (independence, adequacy, escalation) Design transfer and production readiness Design changes, impact assessments, and re‑validation triggers Assessment of residual risk and risk-benefit justification Strong understanding of Quality Management System (QMS) standards. Experience with risk-based auditing and familiarity with GxP principles. Experience with product submissions or regulatory audits is desirable. 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 $99,300.00 - $198,700.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Operations Quality

DIVISION

AQR Abbott Quality and Regulatory

LOCATION

United States >

Abbott Park :

AP52 ADDITIONAL LOCATIONS

WORK SHIFT:

Standard TRAVEL:

Yes, 50 % of the Time

MEDICAL SURVEILLANCE

No

SIGNIFICANT WORK ACTIVITIES

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link -

English:

http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link -

Espanol:

http://webstorage.abbott.com/common/External/EEO_Spanish.pdf Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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