Director, Device, Global Regulatory Affairs

Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes.

Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

The Director, Device, Global Regulatory Affairs is responsible for developing and leading global regulatory strategies for the device component of drug-device combination products. This position works with the technical and device strategy team to ensure the device development, verification, validation, and manufacturing activities meet the regulatory requirements in compliance with combination product frameworks (ie 21 CFR Part 4, ISO 13485, EU MDR).

The Director provides regulatory leadership across device quality, engineering, human factors, and commercial readiness activities while serving as a key interface with global health authorities and Liquidia’s device manufacturing partners on health authority and device-related topics.

• Develops and implements global regulatory strategies for the medical device component of the drug-device combination in conjunction with the regulatory team member and other SMEs supporting clinical development and commercialization.
• Leads preparation of high-quality Module 2 and Module 3 documentation for INDs, CTAs, BLAs, MAAs, and lifecycle submissions. This includes IMPDs, annual reports, and post-approval changes.
• Supports regulatory strategies for applicability of device standards and guidance for the device component of the combination product for manufacturing changes, comparability protocols, and post-approval commitments.
• Serves as the primary device regulatory subject matter expert during interactions with the FDA, EMA, and other global health authorities.
• Supports responses to health authority questions, specific advice, and regulatory intelligence monitoring.

• Collaborates closely with Device Strategy, Manufacturing, CMC, Quality, Clinical Development, technical team members, device partners, and vendors to align development and post-marketing activities with global regulatory requirements for filings and maintenance.
• Ensures combination product design control activities meet regulatory expectations, including user needs, risk management (ISO 14971), design verification/validation, and DHF/DMR/Technical File readiness.
• Supports human factor programs, including study design, protocol review, and regulatory alignment for HF validation studies.
• Guides regulatory requirements to combination product cGMP compliance under 21 CFR Part 4.

• Leads, authors, and reviews device related documents for health authority filings such as device sections of Module 3, Device Master File components (as applicable). Provides input and review to DHF/Technical File summaries, and human factor engineering reports.
• Reviews applicable CMC sections of regulatory submissions (NDA/MAA and supplements, IND/CTA, reports or correspondences, annual reports, IND/CTA amendments) and ensures compliance with regulations and standards of health authorities around the world for assigned programs.
• Prepares responses to regulatory authority information requests during the review process to support application approval and maintenance.
• Supports teams for health authority meetings.

• Collaborates with Quality Assurance to ensure device quality system alignment with ISO 13485 and region-specific requirements.
• Supports audits, inspections, and readiness activities for device and combination product components.
• Parti…