Principal Regulatory Affairs
Core
Principal regulatory affairs leader shaping submission and lifecycle strategy for complex surgical platforms (robotic systems, instruments, disposables, imaging, sensing, connected capabilities) from early design through post-market.
Role type
Principal individual contributor regulatory strategy leader
Builds
Regulatory submission strategies and lifecycle plans for surgical robotic systems and associated software/digital features
Domain
Medical devices / Surgical robotics / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy for complex medical device systems, FDA and international regulatory requirements, submission pathways (510k, De Novo, PMA), quality system regulations, consensus standards application, agency engagement, cross-functional influence
Preferred skills
Regulatory Affairs Certification (RAC), international standards development experience, software/digital health/cybersecurity/AI regulatory knowledge
Technologies
FDA, ISO, IEC, AAMI, 21 CFR 820, ISO 13485
Responsibilities
Lead regulatory strategy across surgical platform; advise senior leaders on regulatory options for new products and design changes; develop submission strategies for premarket authorizations; guide preparation of premarket submissions and lead interactions with regulatory agencies; represent company with regulatory agencies and standards bodies; mentor cross-functional teams
Seniority
Principal, hands-on IC with strategic influence and mentorship
