Director, Medical Events Group & Npr – Abbott Diabetes Care

Abbott

Alameda, California, United States
Base: $172,000.00 – $344,000.00; bonus/equity: not...
Not specified
Global medical device reporting regulations
Fda iso 13485 eu mdr compliance
Post-market surveillance leadership
Abbott is seeking a Director for their Medical Events Group and No Product Return (NPR) team in Alameda, California. The role focuses on leading global medical device vigilance and regulatory compliance for Abbott's Diabetes Care products, requiring substantial experience in Quality Systems and Regulatory Affairs

Job Summary

  • The Director will lead global medical device vigilance and post-market surveillance ensuring worldwide compliance with FDA, ISO 13485, and EU MDR standards.
  • Abbott offers a comprehensive benefits package including free medical coverage, high employer retirement contributions, and tuition reimbursement programs.
  • This role requires defining global reporting strategies, leading the Medical Events Group team, and managing investigations for cases where product returns are not available.

Matching Summary

Match Score: 85

Abbott is seeking a Director for their Medical Events Group and No Product Return (NPR) team in Alameda, California. The role focuses on leading global medical device vigilance and regulatory compliance for Abbott's Diabetes Care products, requiring substantial experience in Quality Systems and Regulatory Affairs.

Salary

Base: $172,000.00 – $344,000.00; Bonus/Equity: Not specified; Benefits: Free medical coverage, retirement savings plan, tuition reimbursement

Skills & Requirements

Must-have

  • Global medical device reporting regulations
  • FDA ISO 13485 EU MDR compliance
  • Post-market surveillance leadership
  • Medical event reporting strategies
  • Regulatory audit inspection representation

Nice-to-have

  • Risk management frameworks knowledge
  • Continuous improvement culture fostering
  • External regulatory discussion experience
  • Advanced global vigilance requirements
  • Strategic leadership in complex processes

Key Requirements

  • Bachelor's or Master's degree in scientific field
  • 8-10 years experience in Quality Systems or Regulatory Affairs
  • 5 years of leadership experience managing teams
  • Expertise in FDA MHRA Health Canada EU MDR regulations

Work Rights

Not specified

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