Senior Compliance Auditor I

Senior Compliance Auditor

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.

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 Abbott's 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.