Senior Regulatory Affairs Specialist

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.

Job 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 for the regions assigned (domestic/international). The individual in this role will represent Regulatory for product development and is responsible for ensuring regulatory submissions and registrations are authored and submitted to targeted business project timelines. They will support regulatory and agency inspections or audits as necessary and advise on regulatory strategy to the organization and design teams, including development of global regulatory strategies.

• 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 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 requirements.
• Communicate with regulatory authorities before and during the review of submissions and monitor the progress of the regulatory agency review process.
• 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).
• Act as RA team member on development teams to provide input on design controls and regulatory deliverables; review scientific/engineering material and interpret standards, regulations, and guidance documents.
• Ensure regulatory submissions are authored according to applicable requirements and guidelines, including US FDA 510(k), FDA Pre‑submissions, EU MDR, UK, Health Canada, Australia TGA, and international registrations.
• Maintain US FDA establishment registrations and device listings, GS1 accounts, and GUIDID entries as required.
• Review and assess impact of new regulations/guidance documents, train stakeholders, and support external audits (FDA, MDSAP, EU MDR, UKCA, etc.).
• Support recruitment, hiring, and training of regulatory team members.

• Successful regulatory clearances/approvals in global markets.
• Working knowledge of quality system standards and regulations: 21 CFR 820, ISO 13485, MDSAP, EU MDD/MDR, UKCA.
• Knowledge of risk management standards: ISO 14971, IEC 60601, IEC 62304.
• Experience with regulatory strategy and approval approaches.
• Understanding of medical device labeling requirements.
• Effective written and oral communication skills; ability to interact with all levels of the company.
• Proficient in reading, analyzing, and interpreting technical documents and regulations.
• Detail‑oriented, proactive problem solver able to work with minimal supervision.

• Bachelor’s degree in a scientific or regulatory discipline plus 8 years of experience in the medical device industry (or equivalent).
• Minimum 5 years experience in a Regulatory Affairs role.
• Experience interpreting FDA and international guidelines and regulations.
• History of US FDA 510(k) clearances for Class II devices and interactions with regulators.
• Experience with EU MDR, Health Canada, Australia TGA, and international…