Medical Device Expert – Inhalation Products Contract : 6-12 months
Introduction We are currently in search for a Project Manager to lead pulmonary drug delivery development, with a focus on CMC integration, external partners, and regulatory delivery.
Responsibilities Lead integrated planning across CMC, device, formulation, regulatory, quality, and manufacturing
Manage timelines, budget, risks, and development milestones
Align formulation constraints with device design and performance
Oversee design control, DHF, verification, validation, and submission readiness
Manage CMOs, suppliers, and external partners
Lead governance, reporting, and stakeholder communication
Ensure compliance with ISO 13485, MDR, 21 CFR 820, GMP
Qualifications Experience in development of inhalation products, or nasal spray/devices.
Strong CMC and device integration experience
Proven cross-functional project leadership
Experience with CMOs and external partners
Knowledge of design control, DHF, regulatory submissions
Familiarity with ISO 13485, MDR, 21 CFR 820, GMP
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