Senior Project Manager, Clinical Risk Evaluation
Core
Provides technical and strategic expertise for Clinical Risk Evaluation (CRE) across the product development lifecycle for Neuromodulation medical devices.
Role type
Senior IC Clinical Risk Evaluation Program Manager
Builds
Risk Evaluation Files (REFs), Clinical Evaluation Reports (CERs), and regulatory submissions for medical devices
Domain
Medical Devices / Regulatory Operations / Clinical Risk Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk analysis, project management, cross-functional team leadership, regulatory compliance knowledge, clinical data interpretation, stakeholder communication, audit support, mentorship
Preferred skills
Biomedical or medical degree, medical writing experience, active/implantable device experience, publication track record
Technologies
None explicitly listed
Responsibilities
Create and maintain Risk Evaluation Files (REFs), lead risk alignment committee meetings, manage Clinical Evaluation Reports (CERs) and timelines, facilitate communication between internal teams and external CROs, participate in regulatory submissions and audits, provide strategic guidance on clinical data requirements, mentor less-experienced staff
Seniority
Senior, hands-on IC with mentorship duties