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Director of Global Regulatory Affairs

Pall

Miami, FL
17 days ago
$155,000 - $180,000

Job Description

Join Pall Corporation as the Director of Global Regulatory Affairs, where you'll lead compliance efforts across diverse industrial applications. You'll play a key role in ensuring product quality and regulatory adherence while collaborating with teams to drive innovation and impact in life sciences and biotechnology.

Key Responsibilities

  • Interpret federal/state/international regulations for products and processes
  • Advise on impact of regulations and devise compliance strategies
  • Investigate and resolve compliance problems
  • Audit policies and procedures for compliance
  • Prepare regulatory submissions and negotiate with agencies
  • Support manufacturing lines during nonconformance
  • Establish and maintain effective Industrial QMS

Required Qualifications

  • BS/BA in relevant engineering, quality-related field, or material science
  • 15 years of progressive regulatory compliance and/or quality assurance experience
  • Thorough understanding of ISO 9001 and AS9100 standards
  • Good understanding of applicable regulatory requirements covering Food Contact, Product Compliance, and Product Environmental Compliance

Preferred Qualifications

  • Knowledge of GMP and FDA regulations
  • Experience with CAA Part 145/CAA Part 21 standards

Benefits & Perks

Comprehensive benefits packagePaid time offMedical/dental/vision insurance401(k) planBonus/incentive pay