Abbott Quality Systems, Regulatory Compliance Manager in Lake Forest, Illinois
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 103,000 colleagues serve people in more than 160 countries.
As Division Subject Matter Expert (SME), provides compliance oversight and direction for quality systems, quality subsystems and/or key processes.
Incumbent manages and directs global compliance activities; and assesses impact and/or implementation of new or changing regulations to quality systems for Division, manufacturing sites, and/or affiliates.
Incumbent will coordinate and lead inspection/audit readiness activities communicating progress and opportunities for improvement to management as applicable.
Responsible for implementing and maintaining the effectiveness of the quality system.
Identifies and recruits staffing resources to support Divisional scope; multi-site quality system projects.
Manages Division-level; professional staff to achieve Division goals and strategic initiatives.
Interprets regulations and requirements and implements programs and procedures to meet requirements worldwide.
Communicates effectively, influences and negotiates with both internal and external stakeholders, ensuring successful compliance status of the Division, manufacturing sites and/or affiliates.
May manage processes or organizations within the quality system.
The above statements are intended to describe the general nature and level of work being performed; other duties may be performed as assigned.
Position Accountability / Scope
The incumbent will report to the Director, Core Lab Quality Systems and Compliance and will be a direct staff member. It is expected that the individual will interact frequently with Division Management with executive responsibility and therefore requires a high level of competence; confidence and credibility. Strategic and tactical decisions for the Division will be made based upon the information that the individual gathers; provides and/or presents in a management setting.
Minimum of 8 years’ experience in medical device industry or other FDA regulated industry experience.
Bachelor’s degree in a science; technical and/or engineering discipline.
Minimum of 2 years Abbott experience preferred.
Strong working knowledge of CAPA
Experience mentoring and coaching
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com