{"id":844504,"url":"https://alion.io/job/remedyrobotics-head-of-regulatory-affairs","title":"Head of Regulatory Affairs","company":{"id":689742,"name":"Remedy Robotics","domain":"remedyrobotics.com","url":"https://alion.io/company/remedyrobotics","size_band":"51-200","is_staffing_agency":false,"is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":{"grade":"B","score":75,"open_postings":5,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-09-24T05:45:00Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["San Francisco, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":220000,"max":280000,"currency":"USD","period":"year","gross":null,"usd_annual":280000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Computer Vision","optional":false},{"name":"Machine Learning","optional":false}],"status":"live","first_seen_at":"2026-05-19T15:01:22Z","employer_posted_date":"2026-05-19","last_verified_at":"2026-09-24T16:07:27Z","board_verified":true,"closed_at":null,"days_open":128,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":127},"description":"Remedy 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.\nWe are looking to hire a Head of Regulatory Affairs for our Clinical/Regulations Team.\nWhat You’ll Do:\nRegulatory strategy & FDA leadership\nOwn the end-to-end regulatory roadmap from IDE through pivotal trial to PMA or De Novo authorization\n\nServe as primary FDA contact (Q-Subs, pre-sub meetings, deficiency responses, panel prep)\n\nDefine regulatory strategy for AI/ML and autonomous features, including PCCP where applicable\n\nSet and sequence OUS strategy (e.g., CE Mark/MDR and other markets) alongside US timelines\n\nSubmissions & regulatory documentation\nAuthor and lead IDE submission development across engineering, clinical, and quality teams\n\nOwn regulatory content across the Design History File and ensure company-wide submission readiness\n\nLead preparation and response for FDA inspections\n\nWrite and manage Q-Sub (pre-submission) packages\n\nCross-functional execution & alignment\nPartner with Clinical Ops to align protocol execution with FDA-facing submission narrative\n\nCoordinate with Program Management on regulatory timelines and milestones\n\nPartner with Quality on QMS, ISO 13485/14971, IEC 62304, and design controls\n\nRepresent regulatory function in executive and board communications\n\nMinimum Qualifications:\n10+ 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)\n\nHands-on experience authoring IDE and PMA/De Novo submissions, not solely in a managerial capacity\n\nStrong working knowledge of 21 CFR Parts 812, 814, and 820; ISO 13485; and ISO 14971\n\nExperience with FDA guidance for AI/ML-enabled devices and the Predetermined Change Control Plan (PCCP) framework\n\nProven track record of leading FDA pre-submission (Q-Sub) meetings and managing ongoing regulatory correspondence\n\nDemonstrated ability to serve as the primary FDA-facing representative for an organization\n\nExceptional 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 stakeholders\n\nBachelor’s degree required; advanced degree (MS, PhD, JD, MBA) or RAC certification preferred\n\nPreferred Qualifications:\nExperience in surgical robotics, autonomous medical devices, or other novel Class III medical technologies\n\nExperience with FDA Breakthrough Device Designation programs\n\nExperience with Software as a Medical Device (SaMD) and AI/ML-enabled regulatory submissions\n\nExperience developing international regulatory strategies, including CE Mark / EU MDR, PMDA (Japan), NMPA (China), and Health Canada\n\nExperience designing real-world evidence strategies and post-market surveillance frameworks\n\nPrior experience in a startup environment, ideally with responsibility for building or scaling the regulatory function from the ground up\n\nBenefits:\nCompetitive salary, including equity\n\n401k + company match\n\nHealth, dental, and vision insurance\n\n20 days PTO per year\n\nCommuter benefits within the Bay Area\n\nWell stocked snacks and Friday team lunches","description_format":"text","description_chars":3794,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Equity","Vision insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Medical Devices"],"lifecycle":[{"event":"open","at":"2026-09-12T23:41:41Z"}],"liveness":{"score":9,"band":"cold","label":"Long shot","p_open":1,"p_active":0.328,"p_room":0.28,"age_days":127,"expected_fill_days":38,"reasons":["conf:0","win:tail","crowd:"],"computed_at":"2026-09-24T05:45:00Z"},"pay":{"stated_usd_annual":280000,"is_top_pay":true},"html_url":"https://alion.io/job/remedyrobotics-head-of-regulatory-affairs","json_url":"https://alion.io/job/remedyrobotics-head-of-regulatory-affairs.json","meta":{"generated_at":"2026-09-24T19:31:28Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}