Apply📍 United States
💸 90000.0 - 105000.0 USD per year
🔍 Medical Technology
🏢 Company: Heartflow
- Base knowledge of global regulatory requirements
- Project management skills a plus
- Demonstrated team collaboration
- Excellent communication, writing, and editing skills
- Strong Word, Excel, and PowerPoint skills
- Support frequent minor software releases by performing change assessments
- Support EU MDR application and maintenance of technical documentation, including clinical evaluation
- Collaborate with cross-functional teams to drive regulatory project management activities
- Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices
- Collaborate with external partners including regulatory agencies, authorized representatives, importers and distributors
- Gain experience with US FDA submissions
- Provide input to the risk management process to ensure risks are identified and updated during the product life-cycle
- Conduct regulatory surveillance and communicate changes in regulations., standards, and guidances
- Support Quality System management, as needed
- Other relevant duties as assigned
- Ability to work in a fast-paced adaptive environment, self-starter, and strong team player
Project ManagementSoftware DevelopmentWritten communicationDocumentationComplianceExcellent communication skillsCross-functional collaborationQuality AssuranceRisk ManagementChange Management
Posted about 12 hours ago
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