Head of Regulatory Affairs

Remedy RoboticsHead of Regulatory Affairs LocationSan Francisco (hybrid)Employment TypeFull timeDepartmentClinical & RegulatoryCompensation$220K – $280K • Offers EquityRemedy Robotics is a medical technology company developing robotic systems for endovascular intervention. Its proprietary technology combines robotics, machine learning, and advanced computer vision to help physicians perform highly precise endovascular procedures and expand access to life-saving stroke and cardiovascular care. Initially focused on neurovascular intervention, Remedy is addressing the limited availability of specialized treatment for time-critical cardiovascular emergencies, with the long-term goal of enabling expert intervention regardless of patient location. Headquartered in San Francisco, Remedy is backed by DCVC, Blackbird, and Tony Fadell's Build Collective, among others.We are looking to hire a Head of Regulatory Affairs for our Clinical/Regulations Team.What You’ll Do:Regulatory strategy & FDA leadershipOwn the end-to-end regulatory roadmap from IDE through pivotal trial to PMA or De Novo authorizationServe as primary FDA contact (Q-Subs, pre-sub meetings, deficiency responses, panel prep)Define regulatory strategy for AI/ML and autonomous features, including PCCP where applicableSet and sequence OUS strategy (e.g., CE Mark/MDR and other markets) alongside US timelinesSubmissions & regulatory documentationAuthor and lead IDE submission development across engineering, clinical, and quality teamsOwn regulatory content across the Design History File and ensure company-wide submission readinessLead preparation and response for FDA inspectionsWrite and manage Q-Sub (pre-submission) packagesCross-functional execution & alignmentPartner with Clinical Ops to align protocol execution with FDA-facing submission narrativeCoordinate with Program Management on regulatory timelines and milestonesPartner with Quality on QMS, ISO 13485/14971, IEC 62304, and design controlsRepresent regulatory function in executive and board communicationsMinimum Qualifications:10+ years of regulatory affairs experience in medical devices, including direct leadership of at least one Class III device through FDA submission (IDE → PMA or De Novo)Hands-on experience authoring IDE and PMA/De Novo submissions, not solely in a managerial capacityStrong working knowledge of 21 CFR Parts 812, 814, and 820; ISO 13485; and ISO 14971Experience with FDA guidance for AI/ML-enabled devices and the Predetermined Change Control Plan (PCCP) frameworkProven track record of leading FDA pre-submission (Q-Sub) meetings and managing ongoing regulatory correspondenceDemonstrated ability to serve as the primary FDA-facing representative for an organizationExceptional written and verbal communication skills, with the ability to develop submission-quality narratives, present to executive leadership and boards, and effectively engage cross-functional technical stakeholdersBachelor’s degree required; advanced degree (MS, PhD, JD, MBA) or RAC certification preferredPreferred Qualifications:Experience in surgical robotics, autonomous medical devices, or other novel Class III medical technologiesExperience with FDA Breakthrough Device Designation programsExperience with Software as a Medical Device (SaMD) and AI/ML-enabled regulatory submissionsExperience developing international regulatory strategies, including CE Mark / EU MDR, PMDA (Japan), NMPA (China), and Health CanadaExperience designing real-world evidence strategies and post-market surveillance frameworksPrior experience in a startup environment, ideally with responsibility for building or scaling the regulatory function from the ground upApply for this Job