Heartflow · 20 hours ago
Senior Regulatory Affairs Specialist
Rohnert Park, CA
Full-time
Hybrid
Mid, Senior Level
$110K/yr - $145K/yr
3+ years expHeartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology. The Senior Regulatory Affairs Specialist is responsible for coordinating and supporting regulatory activities for Heartflow products, ensuring compliance with global requirements while navigating evolving regulatory landscapes.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical
Responsibilities
Represent Regulatory Affairs on cross-functional teams (as necessary) to ensure regulatory alignment with business objectives and timely submissions
Facilitate development of global regulatory strategies for Heartflow products through interfacing with internal (product teams) and external partners (distributors, authorized representatives, international regulatory team)
Review regulatory strategies with the RA management team to gain alignment on priorities and understanding of risks
Establish and maintain collaborative relationships and open communication channels with regulatory authorities and ensure all reporting requirements to external regulatory authorities are completed accurately and on time
Maintain regulatory pre-market and post-market commitments and compliance (establishment registrations, certifications, reporting, special controls, etc) and related activities
Support development of SOPs and internal guidance
Ensure applicable regulatory requirements are considered and appropriately incorporated into projects to ensure compliance
Manage worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and/or market release
Provide on-going support to core and project teams for regulatory issues and questions. Find, interpret, and apply regulations and guidance appropriately for situations
Support Quality organization as necessary in audits and initiatives
Qualification
Required
Bachelor's degree in Science, Engineering, or a related field
Minimum of 3 years of Regulatory Affairs medical device experience
Familiarity with current regulatory thinking around software and AI medical device software development
Direct experience with previously demonstrated examples for generating modular submission documentation and working with various regulatory agencies (e.g. FDA, Notified Bodies)
Strong problem-solving skills and the ability to work independently as well as collaboratively in a team environment
Leadership and interpersonal skills to develop and manage good working relationships within Regulatory Affairs and with other internal departments (R&D, Product, Quality etc)
Excellent communication (written and verbal) and stakeholder management skills to facilitate collaboration across teams and external partners
Strong project management skills with the ability to coordinate cross-functional teams and manage multiple regulatory projects/initiatives
Preferred
1 year working with software as a medical device (SaMD) preferred
Company
Heartflow
Heartflow is a medical technology company that provides various methods of diagnosis and treatment of cardiovascular disease.
501-1000 employees
H1B Sponsorship
Heartflow has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (6)
2022 (9)
2021 (12)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$890.72MKey Investors
Bain Capital Life SciencesPanorama Point PartnersCapricorn Investment Group
2025-08-08IPO
2025-03-26Convertible Note· $98M
2023-04-06Series F· $215M
Leadership Team
John Farquhar
President and CEO
Campbell Rogers
Chief Medical Officer
Recent News
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-22
GlobeNewswire
2026-01-16
Company data provided by crunchbase