Senior Regulatory Affairs Specialist

813

Base: $113,025 - $165,770; bonus/equity: cash-base...
7+ years us and international regulatory experience
Fda, mdd, pmda, tga, and tpd submission knowledge
Iso 9000 and fda quality system regulations expertise
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 develop US and International regulatory strategies for product submissions, identifying needs for bench, animal, and clinical testing while participating on Product Development teams.
  • 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

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; Benefits: Comprehensive package including medical, dental, vision, 401(k) match, and paid time off

Skills & Requirements

Must-have

  • 7+ years US and International regulatory experience
  • FDA, MDD, PMDA, TGA, and TPD submission knowledge
  • ISO 9000 and FDA Quality System regulations expertise

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 medical device regulatory submission experience
  • Knowledge of applicable laws regulating medical device manufacturers

Work Rights

Not specified

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