Senior Regulatory Affairs Specialist

Hyperfine(1 month ago)

HybridFull TimeSenior$116,729 - $157,364 (estimated)Regulatory Affairs

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.

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Required Skills

Regulatory Strategy
Regulatory Submissions
Agency Interaction
Global Registrations
EU MDR
FDA 510k
Health Canada
TGA Submissions
Risk Management
ISO 13485

+10 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.