Senior Regulatory Affairs Specialist

Hyperfine(1 month ago)

HybridFull TimeSenior$119,644 - $161,153 (estimated)Regulatory Affairs

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.

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Required Skills

Regulatory Strategy
Submissions
Agency Interactions
Global Registrations
Compliance Management
Quality Systems
Risk Management
Labeling Review
Technical Writing
Auditing

+5 more

Qualifications

Bachelor's Degree in Scientific or Regulatory Discipline

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.