What are the responsibilities and job description for the Director of Global Regulatory Affairs position at Pall?
Bring More to Life
You are ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology.
We thrive on helping our customers solve their toughest challenges in high-tech filtration, separation, and purification. Our products serve diverse, global customer needs across a wide range of applications to advance health, safety, and environmentally responsible technologies.
Director Global Quality and Regulatory Compliance
JOB SUMMARY
Interprets federal/state/international regulations as they apply to our products, processes, and/or procedures advises on impact of regulations devises strategies for compliance and liaison with regulatory bodies.
Investigates and resolves compliance problems questions and complaints audits and evaluates current policies procedures and documentation for compliance with regulations and statutes.
POSITION OBJECTIVES
- Responsible for the effective implementation of the organization's compliance reporting activities for all Business units within Pall Industrial including Aerospace Energy Microelectronics and Food and Beverage applications.
- Responsible for ensuring product meets all product claims specifications and regulatory requirements throughout the product lifecycle.
- Establishes and maintains an effective Industrial QMS that provides compliance to relevant international standards customer requirements and regulatory requirements.
- Maintains oversight of regulatory requirements to ensure changes are adopted with minimum disruption to implemented controlled and sustained throughout the business and meet PO requirements.
- Proactively Engage with R&D/Design engineering and Product planning teams to ensure new product/material design complies with regulatory requirements for intended markets.
EDUCATION/PRIOR EXPERIENCE REQUIREMENTS
- BS/BA REQUIRED with a preferred relevant engineering major Quality related field or material science fields with 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 and other ISO standards an advantage.
- Good understanding of applicable regulatory requirements covering Food Contact Product Compliance (Ce Marking ATEX ASME etc.) Product Environmental Compliance (ROHS/REACH) and airworthiness (CAA/FAA).
