Senior Regulatory Affairs Specialist

Heartflow•Rohnert Park, CA

13h•$110,000 - $145,000

About The Position

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 FFRCT 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 (FFRCT 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. 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. 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. This individual contributor role provides world-class regulatory support for Heartflow products, ensuring compliance with applicable global requirements while proactively navigating evolving regulatory landscapes. 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.

Requirements

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.
Bachelor's degree in Science, Engineering, or a related field
Minimum of 3 years of Regulatory Affairs medical device experience

Nice To Haves

1 year working with software as a medical device (SaMD) preferred

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.