Senior Regulatory Affairs Specialist
Hyperfine
About this role
The Senior Regulatory Affairs Specialist advises on regulatory strategy and ensures medical devices meet domestic and international regulatory requirements. This role represents Regulatory Affairs on product development teams, authors and submits regulatory filings, and interacts with regulatory agencies and senior leadership. The position also supports audits, maintains registrations and regulatory infrastructure, and helps train and grow the regulatory team.
Skills
Qualifications
About Hyperfine
hyperfinemri.comHyperfine is a medical imaging company that developed the Swoop® Portable MR Imaging® system to bring brain MRI to the point of care. Their compact, wheeled low-field scanner enables bedside neuroimaging in hospitals, ICUs, neurology clinics and pediatric settings, reducing the need for patient transport and accelerating clinical decision-making. Hyperfine combines simplified hardware, clinical workflows and cloud-enabled software (their Swoop system is FDA-cleared for head imaging) to expand access to MRI, lower costs, and improve care delivery.
Recent company news
Simply Wall StreetHyperfine (Nasdaq:HYPR) - Stock Analysis
2 days ago
Business WireHyperfine Announces NEURO PMR Study Results Showing High Diagnostic Value and Superior Patient Experience in Neurology Clinics
Jan 20, 2026
MarketBeatHyperfine (HYPR) to Release Earnings on Wednesday
1 week ago
Stock TitanPortable MRI study tests contrast agents to sharpen better brain scans
Jan 15, 2026
Radiology BusinessPortable MRI vendor Hyperfine launches public stock offering, misses $3.5M revenue target
Oct 16, 2025
About Hyperfine
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
Unlock Company Insights
View leadership team, funding history,
and employee contacts for Hyperfine.
Salary
$117k – $157k
per year
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