Cybersecurity Specialist (Healthcare/Medical Devices)

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

This position Software Validation and Cybersecurity Specialist works out of our Lake Forest, IL location in the Informatics Division of Abbott Rapid Diagnostics.

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.

Software Validation and Cybersecurity Specialist

Key Responsibilities also include:

• Effectively assess regulatory and validation requirements for computer systems within organization

• Identify and develop all required computer system validation deliverables including but not limited to validation plan, user and functional requirements, regulatory requirements, test strategy, IQ/OQ, deployment plan, traceability matrix, validation summary and others

• Ensures compliance to all relevant Quality System Regulations, and other applicable regulations and standards by providing support for interpretation of regulations, performing gap analysis, and leading activities to implement improvements.

  • Experience in ISO13495, CFR 820, 21 CFR Part 11, HIPAA, Data Privacy, GDPR, NIST cybersecurity Framework, FDA Computer System Validation Guidelines, FDA Computer System Assurance

• Provide verification/validation activities project estimates per the department operating procedures.

• Develop, own and execute to well defined timeline and project plan

• Create, develop, and report metrics on the ongoing and pipeline projects

• Coordinate Cybersecurity and Data Integrity actions for sites

  • Identify gaps and actions with milestones

  • Ensure all milestones are achieved on time

  • Establish and execute to the escalation process for issues and concerns

• Conduct product cybersecurity risk assessments in regulated industries such as healthcare (medical and diagnostic devices).

• Evaluate the security of products, software, and systems for compliance with applicable standards (ISO 27001, NIST, EU Directives, FDA, etc.).

• Assess and identify the impact of changes, updates, or new regulations on existing and new products, guiding teams on necessary implementations.

• Collaborate with Systems Engineering, Software Development, Regulatory, and other stakeholders to develop and document cybersecurity controls.

Requirements

• Bachelor degree in Computer Science, Information Technology, Healthcare Technology, Life Sciences, or related discipline.   Knowledge of regulations and standards that affect the health care industry.

• 5+ years combined experience in software development, cybersecurity, validation, and/or quality systems in a medical device regulated environment.

• Experience in product cybersecurity risk assessments in