Sr. Regulatory Affairs Manager

Abbott

Lake Forest, IL, United States
Base: $113,300.00 – $226,700.00; bonus/equity: not...
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6+ years regulated industry experience
Clia waiver and lateral flow expertise
Global regulatory submission management
** Abbott is seeking a Sr. Regulatory Affairs Manager for its Lake Forest, IL location, focusing on the Infectious Diseases Division. The role requires expertise in regulatory affairs, particularly in IVD instruments, and offers a comprehensive benefits package alongside opportunities for career growth within a globally recognized company. **

Job Summary

  • This role empowers smarter medical and economic decision-making to help transform the way people manage their health at all stages of life.
  • The position involves significant departmental influence as an expert resource both within Abbott and externally to ensure products meet required legislation.
  • Employees qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan, a high employer contribution retirement savings plan, and tuition reimbursement.

Matching Summary

Match Score: 75

** Abbott is seeking a Sr. Regulatory Affairs Manager for its Lake Forest, IL location, focusing on the Infectious Diseases Division. The role requires expertise in regulatory affairs, particularly in IVD instruments, and offers a comprehensive benefits package alongside opportunities for career growth within a globally recognized company. **

Salary

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

Skills & Requirements

Must-have

  • 6+ years regulated industry experience
  • CLIA Waiver and Lateral Flow expertise
  • Global regulatory submission management
  • IVD instruments and software knowledge
  • Strategic planning for product lifecycle

Nice-to-have

  • Mentoring regulatory professionals
  • Experience with FDA, IVDR, PMDA
  • Cybersecurity and EMC requirements
  • Acquisition due diligence skills
  • Trade association monitoring

Key Requirements

  • Bachelor's degree in science or related field
  • Master's degree or MBA preferred
  • RAC certification is a plus
  • Ph.D. in technical area or law helpful
  • 7+ years of regulatory experience

Work Rights

Not specified

Tailored Resume

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