As the Director of Global Regulatory Affairs at Pall Corporation, you will lead compliance reporting and ensure products meet all regulatory requirements. You will work closely with R&D and engineering teams to maintain quality standards and execute market approvals, contributing to impactful innovations in life sciences and biotechnology.
Key Responsibilities
Interpret federal/state/international regulations for products, processes, and procedures
Advise on impact of regulations and devise strategies for compliance
Liaison with regulatory bodies
Investigate and resolve compliance issues
Audit and evaluate current policies and documentation for compliance
Prepare regulatory submissions and negotiate agency questions
Support manufacturing lines with nonconformance issues
Required Qualifications
BS/BA in 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
GMP, FDA knowledge and other ISO standards
Good understanding of applicable regulatory requirements covering 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) planBonus/incentive pay