Aerospace Regulatory Engineer
New Port Richey, FL - USA
Job Summary
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology
AtPallCorporation one ofDanahers15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessingDanahers 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 papereveryday 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 theDanaher Business Systemwhich makes everything possible.
The Aerospace Regulatory Lead is responsible for ensuring compliance every day by leading regulatory affairs support for Palls Aerospace business. This role interprets aerospace regulatory certification standards customer and contractual requirements and translates them into actionable business and compliance requirements. The role will support product lifecycle activities customer regulatory inquiries audit readiness regulatory intelligence quality system governance and cross-functional regulatory risk management for aerospace products manufacturing operations and services.
This position reports to the Director Global Regulatory Affairs and is part of the Global Regulatory Affairs team supporting the Pall Aerospace business within the Quality Affairs Regulatory Affairs (QARA) function. This role is expected to be onsite at the Pall Aerospace New Port Richey Florida location with travel to Pall sites customers suppliers or regulatory and industry meetings as needed.
In this role you will have the opportunity to:
- Serve as the Regulatory Affairs lead for Pall Aerospace ensuring compliance with applicable aerospace regulations certifications standards customer requirements and contractual obligations throughout the product lifecycle.
- Interpret regulatory quality aviation authority defense and customer flow-down requirements providing practical guidance and regulatory risk management support to cross-functional teams.
- Lead regulatory intelligence impact assessments and change management activities related to new products product and process changes supplier changes evolving regulations industry standards and customer requirements.
- Support and conduct customer and regulatory audits. Ensure audit readiness and compliance governance through inspections certifications due diligence reviews QMS improvements and development of regulatory procedures standard work and audit traceability systems.
- Develop and maintain customer-facing compliance documentation regulatory response packages dashboards regulatory and risk registers and management reporting while leading cross-functional initiatives that drive regulatory compliance continuous improvement and risk reduction.
The essential requirements of the job include:
- Bachelors degree
- 3 years of experience in regulatory affairs or a related technical function
- Working knowledge of aerospace quality systems regulatory compliance programs product qualification concepts customer flow-down requirements and contractual compliance obligations.
- Experience supporting customer audits internal audits certification audits regulatory inspections compliance assessments or corrective action activities.
- Ability to interpret complex technical regulatory quality and contractual requirements and translate them into clear business actions documentation requirements and cross-functional implementation plans.
Travel Requirements:
- Ability to travel domestically 20-30% within the United States and occasionally internationally to Pall manufacturing sites customer locations supplier locations audits regulatory meetings or industry events based on business needs.
It would be a plus if you also possess experience/expertise in:
- A complex manufacturing environment
- Global regulations and standards impacting Palls Aerospace portfolio including:
- AS 9100 ISO 9001
- CAA CAAC EASA FAA
- ITAR FAR and DFAR
- AD-DSL CE marking ATEX PED NADCAP
Additional Information:
Pall Corporation a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job.
We offer a 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 other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.
Join our winning team today. Together well accelerate the real-life impact of tomorrows 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 .
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.
For candidates who are based outside of New York City or who are applying for roles outside of New York City for more information about conditions of any job offer please click 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- or .
Required Experience:
IC
About Company
WHO WE ARE We are a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. These are the moments that make a difference. Performing a delicate operation on an unborn baby. Minimizing waste at ever ... View more