Director of Global Regulatory Affairs at Danaher - Canada

Munsons Corners, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Jan, 26

Salary

180000.0

Posted On

11 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Compliance, Quality Assurance, ISO 9001, AS9100, GMP, FDA Knowledge, Product Compliance, Environmental Compliance, Airworthiness, Engineering, Product Lifecycle, Continuous Improvement, Auditing, Documentation, Problem Solving, Collaboration, Negotiation

Industry

Medical Equipment Manufacturing

Description

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. And 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/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. Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure 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. Respond to regulatory agency inquiries. Support the 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. 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) The salary range for this role is 155,000 - 180,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole 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. 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. 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, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.

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Responsibilities

The Director of Global Regulatory Affairs interprets regulations and devises compliance strategies while liaising with regulatory bodies. They are responsible for ensuring products meet all specifications and regulatory requirements throughout their lifecycle.