Dist. Scientist, Regulatory Liaison
Core
Senior regulatory leader developing and overseeing global regulatory strategies for companion diagnostics and in vitro diagnostic (IVD) products to support global registration.
Role type
Executive Director, Regulatory Strategy & Team Leadership
Builds
Companion diagnostics and IVD product registration pathways
Domain
Medical Devices / In Vitro Diagnostics / Companion Diagnostics
Required skills
Regulatory strategy, IVD product development, FDA interaction, global registration, team leadership, scientific judgment, risk assessment, stakeholder management, submission preparation, labeling negotiation
Preferred skills
Advanced degree (Master's/PhD), experience with diagnostic partners, regulatory due diligence, policy advocacy