The Hyperfine, Inc. Swoop® Portable MR Imaging® system brings brain imaging to the patient at the point of care. Backed by GV.
About the role
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
What they're looking for
- Bachelor’s degree in a scientific or regulatory discipline, plus 8 years' experience in the medical device industry, or equivalent work experience
- Minimum 5 years' experience in Regulatory Affairs role
- Experience interpreting FDA and international guidelines and regulations
- History of successful US FDA 510(k) clearances for Class II devices and interactions with regulators
- Experience with EU MDR, Health Canada, and Australia TGA regulatory submissions
- Experience with international registrations
More about this role
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
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 project timelines. They will be responsible for ensuring internal...
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