Senior Regulatory Affairs Specialist

Integer

Base: $113,025 - $165,770; bonus/equity: cash-base...
Not specified (potentially hybrid or onsite based on industry standards)
7+ years medical device regulatory experience
Fda mdd pmda tga tpd submission expertise
Iso 9000 and fda quality system knowledge
Integer is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for medical device approvals in the U.S. and international markets, emphasizing compliance with FDA, EU, and ISO standards. The ideal candidate should have over seven years of regulatory experience, strong technical writing skills, and the ability to collaborate across teams

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/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

Match Score: 85

Integer is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for medical device approvals in the U.S. and international markets, emphasizing compliance with FDA, EU, and ISO standards. The ideal candidate should have over seven years of regulatory experience, strong technical writing skills, and the ability to collaborate across teams.

Salary

Base: $113,025 - $165,770; Bonus/Equity: Cash-based incentive program; Benefits: Comprehensive package including medical, dental, vision, 401(k) match

Skills & Requirements

Must-have

  • 7+ years medical device regulatory experience
  • FDA MDD PMDA TGA TPD submission expertise
  • ISO 9000 and FDA Quality System knowledge
  • Strategic planning for product approvals
  • Post-market incident report evaluation

Nice-to-have

  • Strong communication and technical writing skills
  • Experience with supplier and customer relations
  • Ability to work through difficult issues
  • Collaborative team player mindset
  • Openness to new methodologies

Key Requirements

  • Bachelor's degree in a related field
  • 7+ years of regulatory submission experience
  • Knowledge of FDA and ISO regulations
  • US and International market experience

Work Rights

Not specified

Tailored Resume

Cover Letter