Senior Regulatory Affairs Specialist

661

Base: $113,025 - $165,770; bonus/equity: cash-base...
Not specified
7+ years medical device regulatory experience
Fda, mdd, pmda, tga, tpd submission expertise
Knowledge of fda quality system regulations
Integer is seeking a Senior Regulatory Affairs Specialist with extensive experience in U.S. and international medical device regulatory submissions. The role involves strategic planning and oversight of regulatory activities to ensure compliance with various regulatory standards, while promoting a culture of customer focus, 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 must possess a Bachelor's degree and at least 7 years of US and International medical device regulatory submission experience including FDA, MDD, PMDA, TGA, and TPD.
  • 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.

Matching Summary

Match Score: 85

Integer is seeking a Senior Regulatory Affairs Specialist with extensive experience in U.S. and international medical device regulatory submissions. The role involves strategic planning and oversight of regulatory activities to ensure compliance with various regulatory standards, while promoting a culture of customer focus, collaboration, and integrity.

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 expertise
  • Knowledge of FDA Quality System regulations
  • ISO requirements and international standards knowledge
  • Strong technical writing and communication skills

Nice-to-have

  • Experience with supplier and customer relations
  • Ability to work through difficult issues
  • Skill in auditing and training
  • Collaboration within product development teams
  • Openness to new methodologies for quality systems

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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