Senior Regulatory Affairs Specialist

<div class="content-intro"><p>Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFR<sub>CT </sub>Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFR<sub>CT </sub>Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.</p> <p>Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.  </p></div><p>The Senior Regulatory Affairs Specialist is responsible for coordinating and supporting regulatory activities pertaining to successful pre-market development, continued new market entry, and post-market activities for Heartflow products.</p> <p>This individual contributor role provides world-class regulatory support for Heartflow products, ensuring compliance with applicable global requirements while proactively navigating evolving regulatory landscapes.</p> <p>This position is responsible for activities related to regulatory approval to market Heartflow products from development to post-market surveillance.  He/she will be responsible for the assessment of device changes for regulatory impact and develop strategies for submissions and maintenance of documentation within the shifting framework of regulatory requirements worldwide in an efficient manner.  </p> <p><span style="text-decoration: underline;"><strong>Job Responsibilities</strong><strong>:</strong></span></p> <p>Regulatory Project Management</p> <ul> <li>Represent Regulatory Affairs on cross-functional teams (as necessary) to ensure regulatory alignment with business objectives and timely submissions.</li> <li>Facilitate development of global regulatory strategies for Heartflow products through interfacing with internal (product teams) and external partners (distributors, authorized representatives, international regulatory team).</li> <li>Review regulatory strategies with the RA management team to gain alignment on priorities and understanding of risks.</li> <li>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.</li> </ul> <p>Regulatory Operations and Compliance</p> <ul> <li>Maintain regulatory pre-market and post-market commitments and compliance (establishment registrations, certifications, reporting, special controls, etc) and related activities.</li> <li>Support development of SOPs and internal guidance.</li> <li>Ensure applicable regulatory requirements are considered and appropriately incorporated into projects to ensure compliance.</li> <li>Manage worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and/or market release. </li> ... (truncated, view full listing at source)