Senior Regulatory Affairs Specialist

636

Base: $113,025 - $165,770; bonus/equity: cash-base...
Not specified (assumed office-based or hybrid).
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 for medical devices, ensuring compliance with FDA, EU, ISO, and other standards. The ideal candidate will have over seven years of regulatory submission experience and strong communication skills, contributing to a culture of collaboration and integrity

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 will 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, 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 devices, ensuring compliance with FDA, EU, ISO, and other standards. The ideal candidate will have over seven years of regulatory submission experience and strong communication skills, contributing to a culture of collaboration and integrity.

Salary

Base: $113,025 - $165,770; Bonus/Equity: Cash-based incentive program; Benefits: Comprehensive package with immediate eligibility

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

Work Rights

Not specified

Tailored Resume

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