What you'll do

• Leadership and Strategy: Create and lead the strategy for the clinical research team, align with business objectives, and drive innovation and excellence
• Clinical Trial Management: Lead the planning and execution of clinical trials, ensuring quality, budget, and timeline adherence, and manage site selection
• Regulatory Compliance: Ensure clinical trials follow US and EU regulations (FDA, EMA) and maintain up-to-date knowledge of regulatory requirements
• Data Management and Reporting: Oversee clinical data collection, analysis, and reporting, and provide strategic recommendations based on trial results
• Post-Market Clinical Follow-Up: Implement strategies to monitor product safety and performance post-market, ensuring compliance with EU MDR
• Cross-functional Collaboration: Work with various departments (R&D, regulatory, medical) to integrate clinical research into product development
• Team Development: Build and manage a high-performing clinical research team, fostering growth and development

What you need

• MD, PhD, or equivalent in a relevant scientific or medical field
• 5+ years of experience in clinical research within the medical device industry, ideally Software as Medical Device (SaMD)
• Proven track record of successfully managing all phases of clinical trials, from early-stage to post-marketing studies, in both the US and EU
• Extensive knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH-GCP)
• You have a commercial focus in the application of regulatory requirements
• Excellent project management and communication skills to coordinate regulatory agencies and consultants
• Display, encourage, and inspire a culture of excellence across our entire organization
• Experience with AI/ML-based medical devices and cardiology medical devices is preferable

About us

At Powerful Medical, we are building global life-saving technology. Our certified product diagnoses cardiovascular diseases (#1 cause of death globally) by scanning ECGs using AI and machine learning. We’re currently cooperating with several leading healthcare providers within the EU and are backed by both European and Israeli VCs.