Principal Regulatory Affairs Specialist
HeartFlow, Inc
- Salary
- $188k - $240k
- Experience
- 10+ yrs
- Location
- San Francisco or Rohnert Park
- Job type
- Full-time
About the role
Bachelor's degree in computer science, biomedical engineering, software engineering, electrical engineering or related field; 10+ years regulatory affairs in medical devices with 4+ years in SaMD/SiMD; experience with 510(k), De Novo, CE Mark; knowledge of IEC 62304, ISO 14971, IEC 82304-1.
About HeartFlow, Inc
Heartflow is a public medical technology company providing clinicians AI-driven software to diagnose and manage coronary disease.
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