As the Director of Global Regulatory Affairs at Pall, you will lead compliance initiatives and ensure that products meet all regulatory requirements. You'll collaborate with R&D and engineering teams to drive innovation while maintaining high standards of quality and safety.
Key Responsibilities
Interpret federal/state/international regulations and advise on compliance strategies
Investigate and resolve compliance problems and questions
Audit and evaluate policies and documentation for regulatory compliance
Prepare regulatory submissions and secure market clearance for products
Support manufacturing lines during nonconformance situations
Required Qualifications
BS/BA in a relevant field
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
GMP, FDA knowledge
Preferred Qualifications
Relevant engineering major
Good understanding of Food Contact, Product Compliance (Ce Marking, ATEX, ASME), Product Environmental Compliance (ROHS/REACH), and airworthiness (CAA/FAA)
Benefits & Perks
Paid time offMedical/dental/vision insurance401(k)Bonus/incentive pay