Title:QA Compliance Specialist
Location:Abbott Park, IL
Duration:6+ Month and conversion to FTE
Job Description
MD division - will direct all regulatory submissions, renewals, labeling, licensing for over 160 countries
Will work with 4-5 shared groups with production release process, IT tools support, evaluations, IFU creation related to regulatory operations
will provide quality management to several business units
will work in a couple specific areas such as regulatory functions, CAPA, and will help with managing and issuing program metrics for reporting/administration
will manage changes to existing and new regulations assessing the impact and will implement solutions based on impact
will do an assessment of quality system process and document
will create and manager procedure template for SH, EP, AVD, business units
will manage process improvement
will drive change and improvements
must understand regulatory process and be quality system oriented/have a background in this
Must come from medical device background/regulatory industry/pharma
Must have 5 plus years of experience in these areas including quality system process and the ability to align the different business units to a regulation
Must be able and experienced to write a process and procedures
Top 5 skills looking for:
CAPA experience
Document Control
Continuous Improvement
Regulatory understanding of functions
Process Assessment
Certification are preferred: ISO 9000, ISO 9001, ISO 13485
Education:Bachelor's degree required - advanced degrees preferred
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, nutritional and branded generic medicines.
Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.