Sr. Regulatory Affairs Manager

Abbott

Lake Forest, IL, United States
Base: $113,300.00 – $226,700.00; bonus/equity: not...
**
6+ years regulated industry experience
Clia waiver product experience
Lateral flow diagnostic experience
** Abbott is seeking a Sr. Regulatory Affairs Manager for its Lake Forest, IL location within the Infectious Diseases Division. The ideal candidate will possess extensive regulatory knowledge and experience, particularly in IVD instruments and software, to ensure compliance with global regulations and to support product registration efforts. **

Job Summary

  • This role empowers smarter medical decision-making by ensuring products meet global legislation within the Infectious Diseases Division.
  • The position requires significant influence to identify regulatory risks, develop strategies, and negotiate with authorities like the FDA and PMDA.
  • Employees benefit from a comprehensive package including free medical coverage, high employer retirement contributions, and tuition reimbursement programs.

Matching Summary

Match Score: 75

** Abbott is seeking a Sr. Regulatory Affairs Manager for its Lake Forest, IL location within the Infectious Diseases Division. The ideal candidate will possess extensive regulatory knowledge and experience, particularly in IVD instruments and software, to ensure compliance with global regulations and to support product registration efforts. **

Salary

Base: $113,300.00 – $226,700.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • 6+ years regulated industry experience
  • CLIA Waiver product experience
  • Lateral Flow diagnostic experience
  • Global regulatory strategy development
  • IVD instruments and software knowledge

Nice-to-have

  • Ph.D. in technical area or law
  • RAC certification from RAPS
  • Experience with cybersecurity requirements
  • Mentoring regulatory professionals
  • Acquisition due diligence experience

Key Requirements

  • Bachelor's degree in science or related field
  • Master's degree or MBA preferred
  • 7+ years of regulatory experience
  • Background in IVD instruments and software
  • Knowledge of US FDA, IVDR, and PMDA regulations

Work Rights

Not specified

Tailored Resume

Cover Letter