Liquidia Corporation
Director, Device, Global Regulatory Affairs
Liquidia Corporation, Morrisville, North Carolina, United States, 27560
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.
Job Summary
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. Responsibilities
Device Regulatory Strategy and Leadership
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. Cross Functional Development and Lifecycle Management
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. Submission Development and Health Authority Interactions
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. Quality System and Compliance Support
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. Participates in developing internal standards, SOPs, and templates for device regulatory activities. Requirements
Education and Experience
Bachelor’s degree in life sciences, engineering, chemistry, biochemistry, or related field. Advanced degree preferred. RAC or similar certification a plus. Approximately 12 years of device and combination product regulatory or related experience in the pharmaceutical industry with device regulatory leadership in biotech or pharmaceuticals. Strong preference for experience with inhalation drug-device combination products. Experience global device regulations, including FDA 21 CFR Parts 4, 820, 801, 803, EU MDR/IVDR, and ISO 13485/14971. Demonstrated success leading device regulatory submissions and interactions with device-focused regulatory authorities. Strong knowledge and experience of drug and device development and life cycle management concepts and interdependencies with the overall development process. Knowledge, Skills, and Abilities
Strong understanding of device classification, regulatory pathways, and global device frameworks (PMA, 510(k), Technical Files, CE marking). Deep knowledge of design controls, risk management, usability engineering, and device quality system requirements. Familiarity with combination product interfaces, including CMC integration and biologic/device development dependencies. Working knowledge of global CMC regulatory requirements, ICH guidelines, and technical development considerations. Ability to provide strategic guidance to cross-functional teams and external vendors. Strong interpersonal, negotiation, and communication skills with experience presenting to regulators and senior leadership. Proven ability to lead in a matrix environment while managing multiple programs simultaneously Demonstrated aptitude for ‘hands‑on’ troubleshooting and problem solving with an exemplary history as a “self‑starter”. Strong desire to work as part of many cross‑functional teams consisting of technical, quality, clinical, and administrative team members. Unrelenting dedication to defining strategies to support business objectives and delivering high quality results. Occasional travel required (
Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more! Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position. Recruiting Agencies, Please Note
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.
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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. Responsibilities
Device Regulatory Strategy and Leadership
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. Cross Functional Development and Lifecycle Management
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. Submission Development and Health Authority Interactions
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. Quality System and Compliance Support
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. Participates in developing internal standards, SOPs, and templates for device regulatory activities. Requirements
Education and Experience
Bachelor’s degree in life sciences, engineering, chemistry, biochemistry, or related field. Advanced degree preferred. RAC or similar certification a plus. Approximately 12 years of device and combination product regulatory or related experience in the pharmaceutical industry with device regulatory leadership in biotech or pharmaceuticals. Strong preference for experience with inhalation drug-device combination products. Experience global device regulations, including FDA 21 CFR Parts 4, 820, 801, 803, EU MDR/IVDR, and ISO 13485/14971. Demonstrated success leading device regulatory submissions and interactions with device-focused regulatory authorities. Strong knowledge and experience of drug and device development and life cycle management concepts and interdependencies with the overall development process. Knowledge, Skills, and Abilities
Strong understanding of device classification, regulatory pathways, and global device frameworks (PMA, 510(k), Technical Files, CE marking). Deep knowledge of design controls, risk management, usability engineering, and device quality system requirements. Familiarity with combination product interfaces, including CMC integration and biologic/device development dependencies. Working knowledge of global CMC regulatory requirements, ICH guidelines, and technical development considerations. Ability to provide strategic guidance to cross-functional teams and external vendors. Strong interpersonal, negotiation, and communication skills with experience presenting to regulators and senior leadership. Proven ability to lead in a matrix environment while managing multiple programs simultaneously Demonstrated aptitude for ‘hands‑on’ troubleshooting and problem solving with an exemplary history as a “self‑starter”. Strong desire to work as part of many cross‑functional teams consisting of technical, quality, clinical, and administrative team members. Unrelenting dedication to defining strategies to support business objectives and delivering high quality results. Occasional travel required (
Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more! Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position. Recruiting Agencies, Please Note
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.
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