Hyperfine

Hyperfine

Senior Regulatory Affairs Specialist

Palo Alto, CA - Hybrid · Senior

Sponsorship not specifiedDetected 105 days ago
Product ManagementPatient CareFDA RegulatoryMedical DevicesLeadershipCommunicationRegulatory Affairs

About the role

  • Job Title: Senior Regulatory Affairs Specialist
  • The individual in this role will also represents Regulatory for product development and is responsible for ensuring regulatory submissions and registrations are authored and submitted to targeted business project timelines.

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.
  • Develop global regulatory strategies and update based on changes in the regulatory landscape.
  • Lead the preparation of all necessary regulatory submissions (as assigned), in compliance with applicable regulatory requirements.
  • Develop and implement regulatory infrastructure for product versions/releases ensuring compliance with internal and global regulatory requirements.
  • 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.

Requirements

  • 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.
  • Effective written and oral communication skills including the ability to interact with all levels of the company.

Company info

  • 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
  • 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.
  • The Senior Regulatory Affairs Specialist advises regulatory strategy for the company's devices and ensures compliance to Regulatory requirements for the regions assigned (domestic/international).
  • They provide expertise in translating complex regulatory requirements into practical, workable plans, as well as interacts with regulatory agencies and with senior leadership to influence company decisions.
Apply directly at Hyperfine →Create a free account for alerts like thisView Hyperfine immigration profile

This listing is sourced directly from Hyperfine's careers page and normalized into a canonical job model.