Senior Regulatory Specialist

Abbott

Pleasanton, CA, United States
Base: $90,000.00 – $180,000.00; bonus/equity: not ...
Product registration submission
Interact with fda
Regulatory liaison
The Senior Regulatory Affairs Specialist will provide support to the Regulatory Affairs department, executing tasks and partnering across business functions with limited supervision

Job Summary

  • The Senior Regulatory Affairs Specialist will provide support to the Regulatory Affairs department, executing tasks and partnering across business functions with limited supervision.
  • Key responsibilities include directing product registration submissions, interacting with regulatory agencies to expedite approvals, and serving as a regulatory liaison throughout the product lifecycle.
  • Abbott offers a comprehensive benefits package including career development, medical coverage, retirement savings plan, tuition reimbursement, and is recognized as a great place to work globally.

Matching Summary

The Senior Regulatory Affairs Specialist will provide support to the Regulatory Affairs department, executing tasks and partnering across business functions with limited supervision.

Salary

Base: $90,000.00 – $180,000.00; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

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

Nice-to-have

  • cross-division business unit model
  • highly matrixed environment
  • fast-paced, changing environment
  • leverage and engage others
  • positive and cooperative communications

Key Requirements

  • Bachelor's Degree (± 16 years) or equivalent
  • Minimum 5 years Technical experience
  • Minimum 4 years regulatory experience in medical device industry
  • Experience with 510(k) applications
  • Experience with PMA supplements
  • Experience with US device regulations
  • Experience with EU and international regulations
  • Ability to travel approximately 5%

Work Rights

Not specified

Tailored Resume

Cover Letter