Senior Manager, Regulatory Affairs
Core
Lead global regulatory strategy and execution for software-driven medical products, including SaMD, SiMD, cloud applications, and AI/ML-enabled features supporting surgical care.
Role type
Senior Manager, Regulatory Affairs (Digital Portfolio)
Builds
Software-driven medical devices, digital health platforms, and AI/ML-enabled surgical tools
Domain
Medical Devices / Digital Health / Software as a Medical Device (SaMD)
Deliverable
production ML models
Required skills
Global regulatory strategy, US premarket submissions (510k, De Novo), FDA software guidance, AI/ML lifecycle monitoring, cybersecurity compliance (SBOM, threat modeling), team leadership, cross-functional influence
Preferred skills
AI/ML-enabled medical devices, PCCPs, robotic-assisted surgery, global health authority engagement, RAC certification
Technologies
FDA 21 CFR 820/QMSR, EU MDR, IEC 62304, IEC 82304-1, IEC 62366-1, ISO 14971, IEC 81001-5-1, HIPAA, GDPR
Responsibilities
Develop and execute global regulatory strategies for digital products; determine device classification and qualification pathways; lead preparation and submission of 510(k) and De Novo filings; guide regulatory strategy for AI/ML functionality and cybersecurity; recruit and develop a high-performing regulatory team; manage department priorities, resourcing, and budget
Seniority
Senior Manager, hands-on IC with people leadership