Product Performance Clinical Lead
Core
Lead clinical expertise and regulatory reporting for medical devices in electrophysiology, heart failure, and vascular product lines.
Role type
Senior clinical group lead (regulatory compliance)
Builds
Regulatory compliance programs and global medical device reporting processes
Domain
Healthcare / Medical Devices / Electrophysiology
Deliverable
client delivery
Required skills
Clinical expertise in patient disease states, regulatory reporting judgment, team leadership, process improvement, risk management
Preferred skills
Cath Lab or hospital setting experience, knowledge of FDA regulations, knowledge of global regulatory reporting requirements
Technologies
None stated
Responsibilities
Determine reportability of product complaints to global regulatory bodies, lead a small team of direct reports, review complaint files for compliance, develop rationales for regulatory decisions, provide training on patient physiology and product use, coordinate Health Hazard Evaluation process
Seniority
Senior, hands-on IC with team leadership