Aerospace Regulatory Engineer
Danaher Corporation
Summary
The Aerospace Regulatory Lead is responsible for ensuring compliance every day by leading regulatory affairs support for Pall's 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.
Job description
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:
- Bachelor's 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 Pall's Aerospace portfolio, including: AS 9100, ISO 9001, CAA, CAAC, EASA, FAA, ITAR, FAR, and DFAR, AD-DSL, CE marking, ATEX, PED, NADCAP
Requirements
- Bachelor's 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
- Ability to travel domestically 20-30% within the United States and occasionally internationally
Benefits
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.