Director of Clinical Affairs
Core
Own end-to-end execution of regulatory-driven clinical studies for FDA-regulated medical devices and SaMD, ensuring successful clearance and payor coverage.
Role type
Director of Clinical Affairs (Medical Devices/SaMD)
Builds
Clinical studies supporting regulatory submissions (510(k), De Novo) and market launch
Domain
Medical Devices / Software as a Medical Device (SaMD) / Digital Health
Required skills
Clinical study design and execution, IRB/Ethics submissions, FDA device regulations (21 CFR), ICH-GCP, ISO 14155, CRO management, Clinical data management (eCRF), Budgeting, KOL relationship management
Preferred skills
Experience with SaMD-specific guidance, Cross-functional program management, Regulatory interaction support
Technologies
eCRF, FDA 510(k), De Novo, 21 CFR Parts 11/50/56/812/820, ICH-GCP, ISO 14155
Responsibilities
Lead study design with regulatory advisors and KOLs; Manage study execution from protocol to final report; Write and manage IRB submissions and informed consent forms; Select and oversee third-party clinical sites; Manage clinical data operations and query resolution; Develop SOPs and scale clinical operations function; Collaborate with regulatory, product, and engineering teams.
Seniority
Director, hands-on leadership