Senior Regulatory Specialist

Abbott

Pleasanton, CA, US
Base: $90,000.00 – $180,000.00; bonus/equity: not ...
Medical device industry experience
Fda and international regulations
Product registration submission
As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities

Job Summary

  • As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities.
  • The role involves directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life.

Matching Summary

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities.

Salary

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

Skills & Requirements

Must-have

  • Medical device industry experience
  • FDA and international regulations
  • Product registration submission
  • Regulatory liaison throughout product lifecycle
  • Quality Management Systems (QMS)

Nice-to-have

  • Cross-division business unit model
  • Highly matrixed and geographically diverse environment
  • Positive and cooperative communications

Key Requirements

  • Bachelors Degree (± 16 years) Technical discipline OR equivalent
  • Minimum 5 years Technical experience
  • At least 4 years regulatory experience in medical device industry
  • Experience with 510(k) applications, PMA supplements
  • US device regulations and/or EU and other international regulations

Work Rights

Not specified

Tailored Resume

Cover Letter