Senior Regulatory Affairs Specialist

Integer

Base: $113,025 - $165,770; bonus/equity: cash-base...
7+ years us and international regulatory submission experience
Fda, mdd, pmda, tga, and tpd regulatory knowledge
Strategic planning for product submissions and approvals
The primary purpose of this job is to strategically plan, execute, and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets

Job Summary

  • The primary purpose of this job is to strategically plan, execute, and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets.
  • Candidates must possess a minimum of 7 years of experience in US and International medical device regulatory submission and approval processes involving FDA, MDD, PMDA, TGA, and TPD regulations.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with company matching contributions.

Matching Summary

Match Score: 85

The primary purpose of this job is to strategically plan, execute, and provide oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets.

Salary

Base: $113,025 - $165,770; Bonus/Equity: Cash-based incentive program available; Benefits: Comprehensive package including medical, dental, vision, 401(k) match, and paid time off

Skills & Requirements

Must-have

  • 7+ years US and International regulatory submission experience
  • FDA, MDD, PMDA, TGA, and TPD regulatory knowledge
  • Strategic planning for product submissions and approvals

Nice-to-have

  • Strong communication and technical writing skills
  • Experience with supplier and customer relations
  • Ability to work through difficult issues collaboratively

Key Requirements

  • Bachelor's degree in a related field
  • Minimum 7 years of relevant regulatory experience
  • Knowledge of FDA Quality System regulations and ISO requirements

Work Rights

Not specified

Tailored Resume

Cover Letter