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Director of Global Regulatory Affairs

Pall

Cortland, NY
12 days ago
155,000 - 180,000

Job Description

As the Director of Global Regulatory Affairs at Pall, you'll lead compliance efforts across multiple business units, ensuring products meet regulatory standards throughout their lifecycle. Join a dynamic team dedicated to innovating solutions that have a real impact on health and safety.

Key Responsibilities

  • Interpret federal/state/international regulations for products, processes, and procedures
  • Advise on the impact of regulations and devise compliance strategies
  • Audit and evaluate policies for compliance with regulations
  • Prepare regulatory submissions and negotiate agency questions
  • Ensure product meets specifications and regulatory requirements

Required Qualifications

  • BS/BA required with a relevant engineering major, 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

Preferred Qualifications

  • GMP knowledge
  • FDA knowledge
  • Other ISO standards knowledge

Benefits & Perks

Paid time offMedical/dental/vision insurance401(k)Bonus/incentive pay