Leader: Indication Prioritization and Clinical & Regulatory Strategy (Nano-Electronic Neural Implants)
Core
Lead the human-translation roadmap and indication-prioritization process for a wireless nano-electronic neural implant platform, spanning late pre-clinical work through global regulatory approvals and commercial launch.
Role type
Strategy-level principal regulatory and clinical lead (neural implants)
Builds
Global regulatory approvals and commercial launch of Class III active implantable neural devices
Domain
Medical devices / Neurotechnology / Regulatory Affairs
Deliverable
client delivery
Required skills
Class III active implantable device development, neural implant/neuromodulation expertise, FDA approval lifecycle management, EU MDR compliance, indication selection strategy, milestone planning, design control, risk management, biocompatibility, electrical safety standards
Preferred skills
nano-scale implant experience, wirelessly powered implants, Breakthrough Device Designation/HDE acquisition, KOL network development, health-economic modeling, AI/ML-enabled algorithms integration
Technologies
FDA IDE, PMA, De Novo, Breakthrough Devices Program, Q-Subs, EU MDR
Responsibilities
Select and justify the beach-head disease indication maximizing clinical success and speed to market; Build and execute regulatory & clinical strategy for FDA, EU MDR, and key ROW jurisdictions; Define and drive the milestone plan from technology advancement and GLP studies to pivotal trials and market approval
Seniority
Senior, hands-on IC with strategic oversight
