Senior Manager, Regulatory Affairs

About the role

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. Learn More Job Title : Senior Manager, Regulatory Affairs Location : Guilford, CT or Palo Alto, CA (Hybrid, 3 days/week) The Senior Manager, Regulatory Affairs owns and executes U.S. and international regulatory strategy for the company's Class II MRI devices and Class I accessory devices across the product lifecycle-from development through commercialization and post-market change management. This role translates complex global regulatory requirements into pragmatic, risk-based plans in a dynamic, fast-paced start-up environment, partnering closely with R&D, Quality, Clinical, Manufacturing, and Commercial teams. The Senior Manager serves as a primary interface with regulatory agencies and Notified Bodies, provides clear recommendations to senior leadership, and builds scalable regulatory processes by mentoring internal staff and managing external consultants.

Responsibilities

• Develop and lead regulatory strategies for Class I devices and Class II MRI devices to enable timely U.S. clearance and global market access in alignment with business priorities.
• Define submission plans, timelines, and resourcing; drive cross-functional readiness in a start-up environment with shifting priorities and accelerated schedules.
• Lead preparation, publishing, and maintenance of regulatory submissions (e.g., FDA 510(k)s, Q-Sub/Pre-Sub interactions as needed, and international registrations such as EU MDR/UKCA, Canada, Australia, and other priority markets), ensuring completeness and compliance with applicable requirements.
• Support product development by guiding teams on regulatory requirements and expectations, including design controls, risk management, software/cybersecurity considerations (as applicable), MRI-related standards, clinical evidence planning, and review of labeling and promotional claims.
• Build and scale regulatory infrastructure (SOPs, templates, submission archives, and decision records) that enables consistent execution and inspection/audit readiness as the organization grows.
• Partner with Quality to support external audits and inspections (e.g., ISO 13485/MDSAP, FDA) and to maintain alignment between regulatory commitments and the QMS.
• Review and approve labeling, instructions for use, and commercial materials for regulatory compliance (U.S. and international), ensuring claims are accurate, substantiated, and aligned to cleared/approved indications.
• Serve as a primary point of contact with global regulatory agencies and Notified Bodies; lead meeting preparation, responses to questions/deficiencies, and negotiation of clear regulatory pathways.
• Recruit, hire, coach, and develop regulatory personnel; effectively select and manage external consultants, testing labs, and submission publishing partners to meet program needs.
• Knowledge, Skill & Abilities:
• Hands-on, detail-oriented, and comfortable operating with ambiguity; proactive problem-solver who can prioritize effectively in a fast-paced start-up environment.
• Demonstrated success leading U.S. and OUS submissions and sustaining activities for Class I and Class II medical devices (preferably imaging/MRI), including managing questions/deficiencies to clearance/approval.
• Strong working knowledge of FDA regulations and expectations (e.g., 21 CFR 807/820, 21 CFR 801), ISO 13485, MDSAP, and global regulatory frameworks (e.g., EU MDR, UKCA, Health Canada).
• Proven ability to lead cross-functional teams through complex regulatory deliverables with clear ownership, on-time execution, and sound judgment balancing speed and compliance.
• Deep experience interpreting and applying FDA guidance, recognized standards, and international requirements; able to translate requirements into clear plans and document-ready content.
• Strong regulatory strategy skills, including pathway assessment, predicate/device comparisons, intended use/indications development, and lifecycle change impact assessments.
• Experienced directly interacting with FDA and international regulators/Notified Bodies, including leading meetings, preparing briefing packages, and managing written responses.
• Excellent written and oral communication skills including the ability to interact with all levels of the company
• Excellent ability to read, analyze and interpret technical documents, professional journals, technical procedures, and regulations
• Ability to work independently with minimal supervision while keeping stakeholders aligned through clear, concise updates and proactive risk escalation.
• Education & Experience:
• Bache

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