Manager, Complaints and Post-Market
Noah MedicalSalary not specified
- Full Time
- Junior (1 to 2 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Healthcare TechnologyIndustries
Requirements
Candidates should possess a Bachelor’s degree and 1-3 years of experience in Regulatory Affairs, demonstrating a strong understanding of regulatory requirements and the ability to resolve a wide range of issues while maintaining compliance to regulations and standards. Familiarity with global regulatory requirements and experience with US FDA submissions is desired.
Responsibilities
The Regulatory Affairs Specialist will support frequent minor software releases by performing change assessments, 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, and support Quality System management as needed. They will also perform change assessments and work in a fast-paced, adaptive environment as a self-starter and team player.
Skills
Regulatory Affairs
Medical Device Regulations
EU MDR
US FDA submissions
Regulatory Documentation
Risk Management
Regulatory Surveillance
Cross-functional Collaboration
HeartFlow
Non-invasive cardiac testing for heart disease
About HeartFlow
HeartFlow provides a non-invasive cardiac test that helps visualize a patient's coronary arteries in detail. This technology allows physicians to diagnose and treat heart disease more effectively without the need for invasive procedures, which reduces risks for patients and costs for healthcare providers. HeartFlow's main clients are healthcare professionals seeking safer diagnostic methods. The company offers several analyses, including FFRCT Analysis and Plaque Analysis, all of which have received FDA clearance and are available in multiple countries, including the United States, the United Kingdom, Japan, and Canada. Unlike many competitors, HeartFlow focuses on providing a comprehensive suite of analyses that enhance treatment planning. The goal of HeartFlow is to improve cardiovascular care by making it safer and more efficient for both patients and healthcare providers.
Key Metrics
Redwood City, CaliforniaHeadquarters
2010Year Founded
$858.5MTotal Funding
SERIES_FCompany Stage
HealthcareIndustries
501-1,000Employees