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Director of Global Regulatory Affairs

Pall

New Port Richey, FL
12 days ago
$155,000 - $180,000

This Job Position Has Expired

This job listing is no longer available for applications. The position may have been filled or the posting period has ended.

Job Description

As the Director of Global Regulatory Affairs at Pall Corporation, you will lead compliance efforts across various business units, ensuring that products meet regulatory requirements and standards. You will collaborate with product development teams and regulatory bodies to facilitate market approvals and maintain product quality throughout the lifecycle.

Key Responsibilities

  • Interpret federal/state/international regulations for products, processes, and procedures
  • Devise strategies for compliance and liaise with regulatory bodies
  • Investigate and resolve compliance problems and audits
  • Prepare regulatory submissions and negotiate resolution of agency questions
  • Support manufacturing lines with regulatory assessments

Required Qualifications

  • BS/BA required with a relevant engineering major or quality-related field
  • 15 years of progressive regulatory compliance and/or quality assurance experience
  • Thorough understanding of ISO 9001 and AS9100 standards
  • GMP and FDA knowledge

Preferred Qualifications

  • Good understanding of applicable regulatory requirements covering Food Contact, Product Compliance, and Product Environmental Compliance

Benefits & Perks

Paid time offMedical/dental/vision insurance401(k)