Abbott is a global healthcare leader providing life-changing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines
Job Summary
Abbott is a global healthcare leader providing life-changing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines.
This role involves significant influence as an expert resource ensuring products meet regulatory legislation and guiding product development throughout the lifecycle.
Abbott offers career development, excellent medical coverage, retirement plans, tuition reimbursement, and is recognized globally as a great place to work.
Matching Summary
Abbott is a global healthcare leader providing life-changing technologies across diagnostics, medical devices, nutritionals, and branded generic medicines.
Salary
Base: $113,300.00 – $226,700.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings, tuition reimbursement
Skills & Requirements
Must-have
Regulatory compliance for IVD instruments
Experience with global regulatory agencies
CLIA Waiver and Lateral Flow expertise
Regulatory strategy development
Product lifecycle regulatory guidance
Negotiation with regulatory authorities
Nice-to-have
Mentoring regulatory professionals
Knowledge of cybersecurity and software requirements
Experience with international regulatory policies
Strategic planning and risk evaluation
Experience in infectious diseases division
Key Requirements
Bachelor’s degree in science or related field
6+ years in regulated industry with regulatory experience preferred
Experience with US FDA, IVDR, PMDA regulations
Background in IVD instruments and software
Preferred M.S. or M.B.A., Ph.D. or law degree helpful