Hyperfine | AI-Powered Portable MRI · 1 month ago
Senior Regulatory Affairs Specialist
Palo Alto, CA - Hybrid
Full-time
Hybrid
Mid, Senior Level
$125K/yr - $145K/yr
5+ years expHyperfine, Inc. is a pioneering health technology company focused on transforming brain imaging with its innovative Swoop® system. The Senior Regulatory Affairs Specialist will guide regulatory strategy for the company's devices, ensuring compliance with regulatory requirements while interacting with regulatory agencies and senior leadership to influence decisions.
Medical Device
No H1B
Responsibilities
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 a 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
Qualification
Required
Bachelor's degree in a scientific or regulatory discipline, plus 8 years' experience in the medical device industry; or equivalent work experience
Minimum 5 years' experience in Regulatory Affairs role
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
Experience interpreting FDA and international guidelines and regulations
History of successful US FDA 510(k) clearances for Class II devices and interactions with regulators
Experience with EU MDR, Health Canada, and Australia TGA regulatory submissions
Experience with international registrations
Proven track record of navigating swiftly and efficiently through the regulatory process as part of a team ensuring project and company success
Extensive experience interpreting FDA and international regulatory guidelines, understanding regulatory strategy and approval approaches, working directly and interacting with regulatory agencies
Experience hosting audits
Preferred
Experience in Research & Development (R&D)
Familiarity with AI-based software, medical imaging, active devices
Benefits
Participate in Hyperfine's corporate bonus and equity plans
Company
Hyperfine | AI-Powered Portable MRI
The Swoop® system brings MR brain imaging within reach.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Maria Sainz
President & CEO
Matthew Rosen
Co-Founder
Recent News
Medical Product Outsourcing
2025-09-05
Company data provided by crunchbase