Senior Regulatory Affairs Specialist

900

Base: $113,025 - $165,770; bonus/equity: cash-base...
Not specified (based on job description)
7+ years medical device regulatory experience
Fda, mdd, pmda, tga, tpd submission knowledge
Iso and fda quality system regulations expertise
Integer is seeking a Senior Regulatory Affairs Specialist to lead and oversee regulatory activities for product approvals in the U.S. and international markets, ensuring compliance with relevant regulations. The ideal candidate should possess extensive experience in medical device regulatory submissions and demonstrate strong communication skills

Job Summary

  • The primary purpose of this job is to strategically plan, execute, and provide oversight to regulatory activities for US and International markets.
  • Candidates must develop regulatory strategies for product submissions and prepare necessary documentation for government agencies to obtain product approval.
  • The company offers a comprehensive benefits package including immediate eligibility for medical, dental, vision, disability, life insurance, and a 401(k) plan with matching.

Matching Summary

Match Score: 85

Integer is seeking a Senior Regulatory Affairs Specialist to lead and oversee regulatory activities for product approvals in the U.S. and international markets, ensuring compliance with relevant regulations. The ideal candidate should possess extensive experience in medical device regulatory submissions and demonstrate strong communication skills.

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 knowledge
  • ISO and FDA Quality System regulations expertise

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

Work Rights

Not specified

Tailored Resume

Cover Letter