Principal Regulatory Affairs Strategist
Core
Principal-level individual contributor responsible for early regulatory and clinical strategy for emerging surgical technologies, shaping intended use, indications, and global market access before submission plans are defined.
Role type
Principal Regulatory Affairs Strategist (Strategy & Advisory)
Builds
Robotic and surgical systems, instruments, accessories, disposables, and associated software/digital capabilities
Domain
Medical Devices / Surgical Robotics / Regulatory Affairs / Clinical Strategy
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Early regulatory strategy development, clinical evidence strategy definition, US and OUS market access planning, stakeholder influence across R&D/Clinical/Product, risk assessment for novel technologies, regulatory pathway selection, study design logic, engagement with FDA/notified bodies
Preferred skills
Advanced degree in engineering/life sciences/clinical science, experience with AI/ML-enabled functionality, software/digital health regulatory considerations, partnership/acquisition readiness strategy
Technologies
FDA, ISO 14155, Good Clinical Practice (GCP), AI/ML-enabled functionality, digital health, cybersecurity
Responsibilities
Develop and lead early regulatory strategy for surgical platforms; Shape product direction regarding intended use, indications, and classification; Define clinical evidence strategy including study design and endpoint selection; Advise senior leaders on regulatory risks and trade-offs; Translate strategies into executable plans; Engage with regulators on difficult questions
Seniority
Principal, hands-on IC with strategic advisory focus
