Senior Regulatory Affairs Specialist

About The Role

Hyperfine, Inc. (Nasdaq: HYPR) is a groundbreaking health technology company redefining 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.

• Assess and advise regulatory strategies to optimize business expectations related to domestic and international commercial 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 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 with the agency.
• 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 (e.g., 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; provide guidance to teams on complex regulatory issues, including review of scientific/engineering material (protocols/reports), interpretation of standards, regulations, and guidance documents.
• Ensure regulatory submissions are authored according to applicable requirements and guidelines (as assigned) including, but not limited to:
  • US FDA 510(k) submissions.
  • US FDA Pre‑submissions (Q‑subs).
  • EU MDR Submissions.
  • UK Submissions.
  • Health Canada submissions.
  • Australia TGA submissions.
  • International registrations, renewals, and amendments.
  • Periodic reporting to regulatory agencies as required.
• Maintain US FDA establishment registrations and device listing per applicable regulatory requirements (as assigned).
• Maintain GS1 account and US FDA GUIDID entries per applicable regulatory requirements (as assigned).
• Review and approve engineering change orders for product modifications (as assigned).
• 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 in recruiting, hiring, and training regulatory team members.

• History of successful regulatory clearances/approvals in global markets.
• Thorough working knowledge of Quality System standards and regulations including but not limited to 21 CFR 820, ISO 13485, MDSAP, EU MDD/MDR, UKCA.
• Thorough working knowledge of risk management and other standards including but not limited to ISO 14971, IEC 60601, and IEC 62304.
• Extensive knowledge of regulatory strategy and approval approaches.
• Strong knowledge of medical device labeling requirements.
• Effective written and oral communication skills including the ability to interact with all levels of the company.
• Proficient ability to read, analyze and interpret technical documents, professional journals, technical procedures, and regulations.
• Ability to navigate effectively through the regulatory process as part of a team ensuring project and company success.
• Detail‑oriented, hands‑on, proactive problem solver.
• Ability to work with minimal supervision.

• Bachelor’s degree in a scientific or regulatory discipline, plus 8 years’…