Senior Regulatory Affairs Specialist

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.

Title: Senior Regulatory Affairs Specialist

Location: Guilford, CT or Palo Alto, CA (Hybrid, 3 days/week)

The Senior Regulatory Affairs Specialist advises regulatory strategy for the company’s devices and ensures compliance with regulatory requirements in the regions assigned (domestic and international). The role translates complex regulatory requirements into practical, workable plans, interacts with regulatory agencies and senior leadership to influence decisions, and represents regulatory functions throughout product development. Key responsibilities include ensuring timely regulatory submissions, maintaining compliance, and supporting inspections and audits.

• Assess and advise regulatory strategies to optimize business expectations related to domestic and international product availability and regulations:
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
  • Determine requirements and options for regulatory submissions, approval pathways, and compliance activities.
  • Develop global regulatory strategies and update them based on changes in the regulatory landscape.
  • Ensure regulatory strategy outputs are properly communicated to development teams and leadership.
• Lead the preparation of all necessary regulatory submissions (as assigned), in compliance with applicable regulatory requirements.
• Communicate and interact with regulatory authorities before and during the development and review of regulatory submissions; monitor the progress of the regulatory agency review process via appropriate communication.
• Develop and implement regulatory infrastructure for product versions/releases ensuring compliance with internal and global regulatory requirements.
• Guide, review, and approve external communications and promotional materials to ensure accurate and compliant corporate messaging.
• Evaluate the regulatory environment and provide internal advice throughout the product life cycle (concept, development, manufacturing, marketing) to ensure product compliance.
• Act as core RA team member on development teams to provide input on design controls and regulatory deliverables, reviewing scientific/engineering material and interpreting standards, regulations, and guidance documents.
• Ensure regulatory submissions are authored according to applicable requirements and guidelines (e.g., US FDA 510(k), Pre‑submissions (Q‑subs), EU MDR, UK, Health Canada, Australia TGA, International registrations, periodic reporting).
• Maintain US FDA establishment registrations and device listings per applicable regulatory requirements.
• Maintain GS1 account and US FDA GUIDID entries per applicable regulatory requirements.
• Review and approve engineering change orders for product modifications.
• Review and assess impact of new regulations/guidance documents applicable to the company.
• Train stakeholders on current and new regulatory requirements to ensure company‑wide compliance.
• Act as RA lead in external audits (FDA, MDSAP, EU MDR, UKCA, etc.) to meet applicable regulatory requirements and maintain QMS certifications.
• Support recruiting, hiring, and training of regulatory team members.

• History of successful regulatory clearances/approvals in global markets.
• Thorough working knowledge of Quality System standards and regulations (21 CFR 820, ISO 13485, MDSAP, EU MDD/MDR, UKCA).
• Thorough working knowledge of risk management and other standards (ISO 14971, IEC 60601, IEC 62304).
• Extensive knowledge of regulatory strategy and approval approaches.
• Strong knowledge of medical device labeling requirements.
• Effective written and oral communication skills with all levels of the company.
• Proficient ability to…