Senior Regulatory Affairs Specialist

Integer

Base: $113,025 - $165,770; bonus/equity: cash-base...
Not specified in the job description.
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
Integer is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities essential for product approvals in the US and international markets. The ideal candidate should have over seven years of experience in medical device regulatory submissions and a strong understanding of FDA and ISO regulations

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, adoption benefits, and a 401(k) plan with company matching.

Matching Summary

Match Score: 85

Integer is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities essential for product approvals in the US and international markets. The ideal candidate should have over seven years of experience in medical device regulatory submissions and a strong understanding of FDA and ISO regulations.

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

Work Rights

Not specified

Tailored Resume

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