Senior Manager, Regulatory Affairs
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 Manager, Regulatory Affairs Location : Guilford, CT or Palo Alto, CA (Hybrid, 3 days/week) The Senior Manager, Regulatory Affairs owns and executes U.S. and international regulatory strategy for the company’s Class II MRI devices and Class I accessory devices across the product lifecycle—from development through commercialization and post-market change management. This role translates complex global regulatory requirements into pragmatic, risk-based plans in a dynamic, fast-paced start-up environment, partnering closely with R&D, Quality, Clinical, Manufacturing, and Commercial teams. The Senior Manager serves as a primary interface with regulatory agencies and Notified Bodies, provides clear reco...