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 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

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 Software Risk and Compliance Auditor with specialized expertise in auditing medical device software to protect patient safety and ensure compliance with regulatory requirements, industry standards, and internal policies. This role involves conducting technical audits across the software development lifecycle, assessing adherence to quality management systems, and supporting continuous improvement initiatives for product software including SAMD, SIMD, Non product software and cloud based applications.

As a Senior Software Risk and 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.

The role requires very 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’ll 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 with focus on Product and Non Product Software including apps across Abbott manufacturing sites
• Plan, execute, and report on internal audits including indepth analysis on medical device software development and validation processes.
• Evaluate compliance with global redulations including FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, IEC 62304, GAMP5 CSV 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 medical device software compliance.
• Review software 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 edication on compliance and quality topics that are key to Abbott businesses
• Develop risk based audit program with oversight for auditing of product and non product software including development of Abbott wide auditor training and competency assessments.
• Analyse compliance risks and communicate trends and opportunities to senior leadership and corporate policy makers.
• Promotes 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.

Required Qualifications

• Four-year degree in a scientific, technical or compliance discipline or equivalent experience
• Lead auditor certificate for Quality System audits desirable

Required Skills

• In-depth knowledge of global software standards and regulations including IEC 62304, ISO 13485, ISO 14971, GAMP 5 CSV and FDA software validation guidance.
• Strong analytical and problem-solving skills with attention to detail.
• Very 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

• 10 years in software design and development in the medical device industry

• Proven track record working on software development and software lifecycle programs including:

• Software as a medical device

• Software within a medical device

• Cloud based applications

• Non product software

• Cybersecurity

• Artificial Intelligence

• Strong understanding of Quality Management Systems (QMS) and software lifecycle standards.

• Experience with risk based auditing and familiarity with GxP principles desirable.

• Experience with product submissions or regulatory audits 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

$129,300.00 – $258,700.00In 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 : AP01A

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