Regulatory Consultant (Medical Devices)

Role Summary

The Regulatory Consultant will provide high‑level regulatory leadership for a combination pharmaceutical product comprising a control and closure system with a device component. This role is critical to ensuring the successful update and maintenance of the Device Master File (DMF) and supporting a US NDA submission with a firm deadline in February. Deep expertise in combination product regulations, design control, risk management, and inhalation technologies is essential.

Key Responsibilitie

• sDevice Master File Management — Lead updates, gap assessments, and alignment of the DMF for the control and closure system, ensuring compliance with FDA expectations for device components within combination product
• s.Combination Product Regulatory Strategy — Provide authoritative guidance on 21 CFR Part 4, combination product pathways, and cross‑functional regulatory requirement
• s.Inhalation Product Expertise — Apply inhalation-specific regulatory knowledge to ensure the device component and drug‑device interface meet performance, safety, and quality standard
• s.NDA Support — Drive dossier delivery for the US NDA, coordinating module content, timelines, and cross-functional inputs to meet the February submission deadlin
• e.Design Control Leadership — Oversee design history file elements, design verification/validation alignment, and documentation readiness for regulatory revie
• w.Risk Management — Ensure risk management activities (per ISO 14971) are robust, traceable, and integrated across drug and device component
• s.Stakeholder Management — Partner with engineering, quality, regulatory, and clinical teams to ensure cohesive and compliant documentatio
• n.Regulatory Authoring & Review — Draft, review, and refine regulatory documents, ensuring clarity, consistency, and alignment with FDA expectation
• s.Project Leadership — Manage timelines, risks, and deliverables with the authority expected at PM, Associate Director, or Director leve

l.Required Experience & Qualificati

• onsProven experience in combination product regulatory affairs (essentia
• l).Strong background in inhalation products, ideally with device‑drug interface experien
• ce.Demonstrated success supporting US NDA submissions, including Module 3 and device‑related conte
• nt.Expertise in design control, risk management, and device documentation syste
• ms.Experience managing Device Master Files or similar device regulatory documentati
• on.Ability to operate at a senior level (PM, Associate Director, or Director) with strategic and hands‑on capabili
• ty.Excellent communication, cross-functional leadership, and regulatory problem‑solving skil

ls….