Director of Global Regulatory Affairs

Bring More to Life

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics, and biotechnology?

At Pall Corporation, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. By harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve their toughest challenges. Our products serve diverse, global customer needs across a wide range of applications to advance health, safety, and environmentally responsible technologies. From airplane engines to hydraulic systems, Scotch to smartphones, OLED screens to paper—everyday Pall is there, helping protect critical operating assets, improve product quality, minimize emissions and waste, and safeguard health.

For the exponentially curious, Pall is a place where you can thrive and amplify your impact on the world. Find what drives you on a team with a more than 75-year history of discovery, determination, and innovation.

Learn about the Danaher Business System which makes everything possible.

Director, Global Quality and Regulatory Compliance

Job Summary

Interprets federal, state, and international regulations as they apply to our products, processes, and/or procedures. Advises on impact of regulations, devises strategies for compliance, and liaises 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.

Determines the need for and prepares regulatory submissions, negotiates the resolution of agency questions, and secures market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on product recalls and responds to regulatory agency inquiries. Supports manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.

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.

Ensures product meets all claims, specifications, and regulatory requirements throughout the product lifecycle.

Establishes and maintains an effective Industrial QMS that provides compliance with relevant international standards, customer requirements, and regulatory requirements.

Maintains oversight of regulatory requirements to ensure changes are adopted with minimum disruption, implemented, controlled, and sustained throughout the business.

Proactively engages 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, preferably in a relevant engineering, quality, or material science field, 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 are 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).

Compensation and Benefits

The salary range for this role is $155,000 – $180,000. This is the range we in good faith believe represents possible compensation for this role at the time of posting and may be modified in the future.

This role is also eligible for bonus/incentive pay.

Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees.

Note: No amount of pay is considered wages or compensation until earned, vested, and determinable. Any bonus, commission, benefits, or other form of compensation remains at the Company’s sole discretion unless and until paid and may be modified at the Company’s discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com
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Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here
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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, or to receive other benefits, please contact 1-202-419-7762 or [email protected]
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