Senior Manager, Regulatory Affairs

Hyperfine • Palo Alto, CA

1d • $162,000 - $208,000 • Hybrid

About The Position

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.

Requirements

• 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.
• Bachelor’s degree required (scientific/engineering discipline preferred) with 15+ years of progressive regulatory affairs experience in medical devices; or Master’s degree with 10+ years of progressive regulatory affairs experience
• Significant hands-on ownership of U.S. and international submissions and post-market change management; advanced degree and/or RAC certification preferred.

Nice To Haves

• Experience in Research & Development (R&D).
• Familiarity with AI-based software, medical imaging, active devices.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees