Senior Regulatory Labeling Specialist

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 FFRCTAnalysis—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 (FFRCTAnalysis), 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 750,000 patients worldwide. At Heartflow, we are revolutionizing cardiovascular care through precision technology. As our Senior Regulatory Labeling Specialist, you won't just manage documentation—you’ll be the bridge between complex engineering innovations and the patients and clinicians who rely on them globally. In this role, you will be responsible for ensuring compliance across core regulatory functions, with a specific focus on authoring and maintaining Instructions for Use (IFU) and other labeling, conducting regulatory reviews of promotional and marketing materials, and leveraging IT systems and databases to streamline documentation and submissions. The ideal candidate bridges technical writing, regulatory compliance, cross-functional collaboration (with Product, Marketing, Engineering), and digital systems literacy to support global product lifecycle management. ### **Key Responsibilities** #### **Labeling & Instructions for Use (IFU) Development** - Lead or support the creation, drafting, and maintenance of Instructions for Use (IFU), product inserts, user manuals, and technical labeling in compliance with applicable standards (e.g., ISO 15223, EU MDR/IVDR, FDA labeling regulations). - Collaborate with cross-functional teams (Product, Engineering, Clinical, and Medical Affairs) to translate technical specs into clear, accurate, and compliant end-user instructions. - Write, copy edit, proofread documents related to the product development and ensure documentation reflects a consistent voice and style - Manage labeling changes through the internal change control system, ensuring document version control and traceability, from development, release, and post-market. - Coordinate localization, translation management, and proofing process for global IFUs and other labeling internally and with 3rd party vendors. - Identify and implement new or improved tools, templates, documentation methods and procedures to maintain efficiency. #### **Marketing & Promotional Material Review** - Under the direction of Management, serve as a regulatory reviewer for marketing and clinical materials - Evaluate advertising, commercial collateral, website copy, digital campaigns, and social media content to ensure claims are substantiated, fair-balanced, and aligned with approved product indications. - Mitigate regulatory exposure by identifying off-label claims or unverified promotional statements and proposing compliant alternative wording. #### **Systems, IT, and Data Management** - Support software release process - Utilize Electronic Document Management Systems (EDMS), Electronic Common Technical Document (eCTD) publishing tools, and Product Lifecycle Management (PLM) software (e.g., MasterControl, Veeva, Arena) to archive and manage regulatory assets. - Maintain and populate internal and external regulatory databases, tracking systems, and global product registration databases (e.g., FDA GUDID, EUDAMED). - Optimize workflows to enhance cross-departmental regulatory efficiency. #### **General Regulatory & Compliance Support** - Assist with compiling, formatting, and organizing regulatory submissions (e.g., 510(k), STED, CE mark technical files). - Monitor changing regulatory requirements, guidance documents, and industry standards related to labeling and promotional activities. - Assist in regulatory audits, inspections, and post-market compliance initiatives as required. ### **Qualifications & Requirements** - **Education:** Bachelor’s degree in life sciences, technical field, or a related discipline. - **Experience:** 5-7 years of experience as a technical writer - **Labeling Expertise:** Proven experience drafting, updating, or reviewing technical documentation, labeling, or IFUs under regulatory frameworks (FDA, EU MDR, etc.). - **Marketing Review:** Hands-on experience with marketing-material review processes and evaluating commercial marketing content against approved indications/claims. - **IT & Systems Proficiency:** High computer literacy with demonstrated proficiency in EDMS, PLM systems, databases, advanced Excel/data tools, and document collaboration platforms (Veeva, MasterControl, SharePoint, TrackWise, etc.). - **Communication:** Excellent written and verbal communication skills with a strong eye for detail, grammar, and technical drafting. - **Project Management:** Ability to manage multiple review requests and projects simultaneously under firm commercial deadlines. ### **Preferred Qualifications** - Familiarity with XML, structured authoring tools, or translation management systems for global IFUs. - Experience with UDI (Unique Device Identification) registration procedures (GUDID, EUDAMED). - Experience with MadCap Flare is a plus. - Hands-on experience with command-line tools, DOS/Batch scripting, and Java environments to support developer documentation and automated publishing build processes is a plus. This position has an estimated base salary of $145,000 - $168,000, bonus, and equity. #LI-IB1 Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination. Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals. Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with “@heartflow.com” and B) the position described is found on our careers site at [](https://www.heartflow.com/about/careers/).