Senior Regulatory Specialist

Abbott

Pleasanton, CA, US
$90,000.00 – $180,000.00; not specified; not speci...
Not specified (assumed hybrid based on industry standards).
Product registration submission
Interact with fda
Regulatory liaison
Abbott is seeking a Senior Regulatory Specialist for its Heart Failure Division in Pleasanton, CA. The role involves supporting product development and regulatory activities while ensuring compliance with FDA and international regulations

Job Summary

  • Abbott is a global healthcare leader that helps people live more fully at all stages of life.
  • As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities.
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

Matching Summary

Match Score: 85

Abbott is seeking a Senior Regulatory Specialist for its Heart Failure Division in Pleasanton, CA. The role involves supporting product development and regulatory activities while ensuring compliance with FDA and international regulations.

Salary

$90,000.00 – $180,000.00; Not specified; Not specified

Skills & Requirements

Must-have

  • product registration submission
  • interact with FDA
  • regulatory liaison
  • medical device regulations
  • Quality Management Systems

Nice-to-have

  • international company
  • team and individual contributor
  • highly matrixed environment
  • positive and cooperative communications

Key Requirements

  • Bachelors Degree or equivalent
  • Minimum 5 years technical experience
  • Minimum 4 years regulatory experience
  • Experience with 510(k) applications
  • Experience with EU/international regulations
  • Ability to travel 5%

Work Rights

Not specified

Tailored Resume

Cover Letter