As the Director of Global Regulatory Affairs at Pall Corporation, you will lead compliance efforts across various business units, ensuring regulatory requirements are met throughout the product lifecycle. Your expertise will help navigate complex regulations and secure market approvals, making a significant impact on health and safety technologies.
Key Responsibilities
Interpret federal/state/international regulations as they apply to products, processes, and procedures
Devise strategies for compliance and liaise with regulatory bodies
Investigate and resolve compliance problems, questions, and complaints
Audit and evaluate current policies and procedures for compliance
Prepare regulatory submissions and negotiate resolution of agency questions
Support manufacturing lines when nonconformance exists
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, CAA Part 145, CAA Part 21 standards
Knowledge of GMP, FDA, and other ISO standards
Good understanding of applicable regulatory requirements covering Food Contact, Product Compliance, and Product Environmental Compliance
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k) planBonus/incentive pay eligibility