Leader: Indication Prioritization and Clinical & Regulatory Strategy (Nano-Electronic Neural Implants)
On-site · Boston, Massachusetts, United States
Job Summary
Lead the human-translation roadmap and the indication-prioritization process for our nano-implant platform. Exposure to AI/ML-enabled algorithms or digital companions integrated with implants is preferred. This role spans late pre-clinical work through global regulatory approvals and launch: Select and justify the beach-head disease indication that maximizes probability of clinical success, speed to market, reimbursement viability, and strategic value. Build and execute the regulatory & clinical strategy (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.
Required Qualifications
- 10+ years in Class III active implantable devices with ≥5 years in neural implants, neuromodulation, or neurostimulation.
- Direct, end-to-end experience bringing at least one neural or active implantable device from late pre-clinical through FDA approval and commercial launch.
- Demonstrated leadership of indication-selection or product-market-fit efforts for a platform technology.
- Deep knowledge of FDA IDE, PMA, De Novo, Breakthrough Devices Program, Q-Subs, and EU MDR processes.
- Hands-on expertise in design-control, risk-management, biocompatibility, and electrical safety standards relevant to neural implants.
- Advanced degree (PhD, MD, MS, or equivalent) in Biomedical Engineering, Neuroscience, Regulatory Affairs, or related discipline.
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