Senior Regulatory Affairs Specialist

809

Base: $113,025 - $165,770; bonus/equity: cash-base...
7+ years us and international medical device regulatory experience
Fda, mdd, pmda, tga, and tpd submission expertise
Knowledge of fda quality system regulations and iso requirements
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 ensuring compliance with relevant FDA, EU, ISO, and other regulatory standards.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, adoption benefits, 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 supporting pay-for-performance philosophy; Benefits: Comprehensive package including medical, dental, vision, disability, life insurance, adoption benefits, parental leave, and 401(k) with matching

Skills & Requirements

Must-have

  • 7+ years US and International medical device regulatory experience
  • FDA, MDD, PMDA, TGA, and TPD submission expertise
  • Knowledge of FDA Quality System regulations and ISO requirements

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
  • 7+ years of medical device regulatory submission/approval experience
  • Knowledge of applicable laws regulating medical device manufacturers

Work Rights

Not specified

Tailored Resume

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