|Location||Green Oaks, IL|
|Date Posted||April 3, 2021|
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 109,000 colleagues serve people in more than 160 countries.
DO WORK THAT MATTERS
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies. The Abbott Rapid Diagnostics (ARDx) division brings a variety of expert viewpoints on new innovations, insights, and impacts that are shaping the future of diagnostics around the world. Product and Non product cyber resiliency is important for the ARDx Division, ensuring safe and secure products and services.
The role will the primary, Divisional SME for ARDx, responsible for:
- Implementation and continuous improvement of good ARDx cybersecurity practices across both product and non-product quality systems to meet compliance and regulatory requirements within the Abbott and ARDx Quality Management Systems.
- Supporting the ARDx Secure Lifecycle Program (SLP), in accordance with the Abbott Software Lifecycle policy and process requirements.
- Briefing ARDx senior management on current and future cybersecurity threats and mitigations.
- Developing and delivering cybersecurity training to key ARDx personnel.
- representing ARDx in cross-divisional, corporate and industry forums.
The ideal candidate should be a subject matter expert in global cybersecurity regulations, guidance’s, standards and best practices with a background in medical device or similar regulated industries
- Acts as the point of contact and subject matter expert .
- Extend the ARDx Quality Systems Framework to Medical Device cyber security and cyber resiliency.
- Monitor cybersecurity trends and evolving practices .
- Responsible for training or overseeing training of divisional staff on applicable cybersecurity, privacy, data protection and Quality Management System requirements.
BASIC QUALIFICATIONS | EDUCATION/EXPERIENCE:
- Bachelor’s degree in Science, Engineering, Quality Assurance or Regulatory Affairs with 10+ years of Cybersecurity experience in a regulated industry.
- Experience with:
- Global cyber security regulations, reference standards, guidance’s and best practices,
- Global privacy and data protection regulations, reference standards, guidance’s and best practices.
- Global cyber security risk management.
- Internet technologies.
- Knowledge of Quality Management Systems, including successful interactions with regulatory bodies.
- Able to interpret regulations, reference standards, guidance’s, best practices and guidelines on cybersecurity, privacy and data protection, and to convert these into practical and pragmatic deliverables.
- Practical knowledge leadership with well-developed interpersonal & communication skills
- Management motivation experience