Regulatory Affairs Manager - International Compliance Operations – Diabetes Care (on-site)

AbbVie

Alameda, California, United States
Base: $114,000.00 – $228,000.00; bonus/equity: not...
International regulatory compliance
Medical device submissions (pma, ide, 510(k))
Qsr, iso, and en standards
Abbott is a global healthcare leader focused on helping people live more fully at all stages of life, with leading businesses in diagnostics, medical devices, nutritionals, and branded generic medicines

Job Summary

  • Abbott is a global healthcare leader focused on helping people live more fully at all stages of life, with leading businesses in diagnostics, medical devices, nutritionals, and branded generic medicines.
  • This role provides end-to-end support for the regulatory department, ensuring efficient and compliant business processes, identifying emerging regulations, and driving timely implementation.
  • Abbott offers a comprehensive benefits package including career development, medical coverage, retirement savings, tuition reimbursement, and is recognized as a great place to work globally.

Matching Summary

Abbott is a global healthcare leader focused on helping people live more fully at all stages of life, with leading businesses in diagnostics, medical devices, nutritionals, and branded generic medicines.

Salary

Base: $114,000.00 – $228,000.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • International regulatory compliance
  • Medical device submissions (PMA, IDE, 510(k))
  • QSR, ISO, and EN standards
  • European community, Japan, Canada regulations
  • Scientific writing experience
  • Cross-functional team collaboration

Nice-to-have

  • Emerging technologies (AI)
  • Building light automations/dashboards
  • Managing small teams
  • Highly matrixed environment
  • Professional certifications (RAC, PMP, Lean/Six Sigma)

Key Requirements

  • Bachelor's degree or equivalent experience
  • Minimum 8 years medical device industry experience
  • 5 years FDA submission preparation
  • Class I, II, and III medical devices
  • Working knowledge of regulatory requirements for multiple countries
  • Strong verbal and written communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter