Hyperfine

Senior Regulatory Affairs Specialist

Hyperfine

3 months ago
Guilford, Connecticut
Hybrid
Full Time
Senior
3 applicants
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Hyperfine
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About this role

The Senior Regulatory Affairs Specialist at Hyperfine is a senior-level regulatory expert supporting the company’s medical imaging products and global market access. The role provides regulatory leadership, ensures alignment with domestic and international requirements, and partners with cross-functional teams and external regulators. The position is based in Guilford, CT or Palo Alto, CA and follows a hybrid on-site schedule.

Skills

Qualifications

Bachelor's Degree in Scientific or Regulatory Discipline
Hyperfine

About Hyperfine

hyperfinemri.com

Hyperfine 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.

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

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