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Open nowPosted 508 days ago

Leader: Indication Prioritization and Clinical & Regulatory Strategy (Nano-Electronic Neural Implants)

cahiratech13 open roles

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Boston, MA
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Your applicationOpen nowLeader: Indication Prioritization and Clinical & Regulatory Strategy (Nano-Electronic Neural Implants)cahiratech · Boston, MA

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This job: posted 508 days ago

The posting

About Cahira Technologies

Cahira has created the world’s first non-surgical, wireless nano-electronic implants that cross the intact blood-brain barrier, enabling neuromodulation with high precision. Having validated the platform in vivo (mice), we are preparing to choose a beach-head indication (BHI) and move rapidly toward first-in-human studies and commercialization.

Role 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

  1. 10+ years in Class III active implantable devices with ≥5 years in neural implants, neuromodulation, or neurostimulation.
  2. Direct, end-to-end experience bringing at least one neural or active implantable device from late pre-clinical through FDA approval and commercial launch.
  3. Demonstrated leadership of indication-selection or product-market-fit efforts for a platform technology.
  4. Deep knowledge of FDA IDE, PMA, De Novo, Breakthrough Devices Program, Q-Subs, and EU MDR processes.
  5. Hands-on expertise in design-control, risk-management, biocompatibility, and electrical safety standards relevant to neural implants.
  6. Advanced degree (PhD, MD, MS, or equivalent) in Biomedical Engineering, Neuroscience, Regulatory Affairs, or related discipline.
  7. Outstanding written and verbal communication skills for regulatory dossiers, investor updates, and KOL engagement.

Preferred Qualifications

  • Experience with nano-scale or wirelessly powered implants.
  • Obtained Breakthrough Device Designation or HDE for a neurotechnology product.
  • Established network of FDA reviewers, neurology / neurosurgery investigators, and reimbursement experts.
  • RAC (US/EU) or PMP certification.
  • Familiarity with health-economic modeling and payer evidence requirements for neuromodulation therapies.
  • Exposure to AI/ML-enabled algorithms or digital companions integrated with implants.
  • Thrives in a fast-paced, resource-constrained startup environment and can scale teams rapidly.
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