Senior Regulatory Affairs Specialist
Hyperfine · Palo Alto, California, US
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA...
Job description
About Us Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Our mission is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Learn More About The Role: Job Title : Senior Regulatory Affairs Specialist Location : Palo Alto, CA or Guilford, CT (Hybrid, 3 days/week) The Senior Regulatory Affairs Specialist advises regulatory strategy for the company’s devices and ensures compliance to Regulatory requirements for the regions assigned (domestic/international). They provide expertise in translating complex regulatory requirements into practical, workable plans, as well as interacts with regulatory agencies and with senior leadership to influence company decisions. The individual in this role will also represents Regulatory for product development and is responsible for ensuring regulatory submissions and registrations are authored and submitted to targeted business proje...