Senior Regulatory Affairs Specialist

81

Base: $113,025 - $165,770; bonus/equity: cash-base...
7+ years medical device regulatory experience
Fda, mdd, pmda, tga, tpd submission knowledge
Iso 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 possess a minimum of 7 years of US and International medical device regulatory submission and approval experience including specific knowledge of FDA, MDD, PMDA, TGA, and TPD requirements.
  • 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: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) match

Skills & Requirements

Must-have

  • 7+ years medical device regulatory experience
  • FDA, MDD, PMDA, TGA, TPD submission knowledge
  • ISO and FDA Quality System regulations expertise
  • Strategic planning for US and International approvals
  • Post-market incident report evaluation skills

Nice-to-have

  • Strong communication and technical writing abilities
  • Experience with supplier and customer relations
  • Ability to work through difficult compliance issues
  • Proficiency in spreadsheet and word-processing software
  • Collaborative team player within product development

Key Requirements

  • Bachelor's degree in a related field
  • 7+ years of medical device regulatory experience
  • Knowledge of FDA Quality System regulations
  • Experience with ISO requirements
  • US and International market regulatory strategy background

Work Rights

Not specified

Tailored Resume

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