Director of Clinical Affairs - Ambulatory Monitoring and Diagnostics
Core
Lead global clinical evidence strategies for ambulatory monitoring and diagnostics products to support regulatory success, product innovation, and clinical adoption in the cardiovascular portfolio.
Role type
Director of Clinical Affairs (Medical Device)
Builds
Clinical evidence programs, scientific communications, and regulatory documentation for cardiovascular monitoring devices.
Domain
Medical Device / Cardiovascular / Ambulatory Monitoring
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical research regulations (FDA, ICH-GCP), study design and protocol development, statistical strategy, risk management, team leadership, budget management, external stakeholder engagement (regulators, KOLs), strategic planning
Preferred skills
Advanced scientific/clinical degree, experience with ambulatory monitoring (Holter, MCOT), remote patient management, AI/predictive analytics in electrocardiography
Technologies
Holter monitors, Mobile Cardiac Output Telemetry (MCOT), AI algorithms, predictive analytics
Responsibilities
Develop global clinical affairs strategy, architect clinical evidence programs across product lifecycle, deliver scientific communications for regulatory submissions, provide clinical input into product development and design controls, lead and develop the Clinical Affairs organization
Seniority
Director, strategic leadership & team management