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. Learn More
About The Role
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.
Key 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:
- 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.
Preferred Qualifications:
- Experience in Research & Development (R&D).
- Familiarity with AI-based software, medical imaging, active devices.
Physical Demands:
- This is a hybrid role based out of Hyperfine's facility in Guilford, CT or Palo Alto, CA (minimum 3 days per week).
- Availability during nights, weekends, and holidays as business needs require.
- Ability to speak, write, and use all office equipment including scanner and printer, phone, computer, etc.
Compensation: The annual base salary for this position based in Hyperfine's Guilford, CT office is between $162,000 - $186,000 (or $180,000 - $208,000 if based in our Palo Alto, CA office). This position is also eligible to participate in Hyperfine's corporate bonus and equity plans. Individual compensation packages are based on various factors unique to each candidate including skill set, relevant experience, qualifications, location, position level, and other job-related reasons.
Work Authorization: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.
Agency Resumes: Hyperfine is not accepting resumes from recruitment agencies. Any unsolicited resumes submitted by agencies will be considered the property of Hyperfine and will not be subject to any fees or charges if the candidate is hired.