Senior Regulatory Affairs Specialist

576

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
Medical device 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 ensuring compliance with FDA, EU, ISO, and other standards.
  • 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 supporting pay-for-performance philosophy; Benefits: Medical, dental, vision, disability, life insurance, adoption benefits, parental leave, 401(k) with matching, 80 hours holidays plus PTO

Skills & Requirements

Must-have

  • 7+ years US and International regulatory submission experience
  • FDA, MDD, PMDA, TGA, and TPD regulatory knowledge
  • Medical device quality system regulations expertise
  • Strategic planning for product development teams
  • Technical writing and communication skills

Nice-to-have

  • Experience with supplier and customer relations
  • Ability to work through difficult issues collaboratively
  • Strong auditing and training capabilities
  • Proficiency in spreadsheet and word-processing software

Key Requirements

  • Bachelor's degree in a related field
  • 7+ years of medical device regulatory submission/approval experience
  • Knowledge of FDA Quality System regulations and ISO requirements
  • Experience with FDA, MDD, PMDA, TGA, and TPD regulations

Work Rights

Not specified

Tailored Resume

Cover Letter