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Salary: USD 145,000 - 168,000 / annual
HeartFlow is a publicly traded medical technology company (HTFL) pioneering AI-driven solutions for coronary artery disease diagnosis and management. The company's flagship product, HeartFlow FFR_CT Analysis, is a non-invasive cardiac test that provides 3D visualization of coronary arteries and blood flow assessment. With international regulatory clearance (US, UK, Europe, Japan, Canada) and deployment across 750,000+ patients globally, HeartFlow is expanding its product pipeline and regulatory team.
As Senior Regulatory Labeling Specialist, you will serve as the critical bridge between engineering innovation and global clinical/patient end-users, ensuring regulatory compliance across labeling, promotional materials, and documentation systems. This is a hybrid role based in the San Francisco Bay Area (San Francisco or Rohnert Park offices).
**Key Responsibilities:**
**Labeling & Instructions for Use (IFU) Development**
- Lead or support creation, drafting, and maintenance of Instructions for Use, product inserts, user manuals, and technical labeling in compliance with ISO 15223, EU MDR/IVDR, FDA regulations, and other applicable standards.
- Collaborate with Product, Engineering, Clinical, and Medical Affairs teams to translate technical specifications into clear, accurate, compliant end-user instructions.
- Write, copy-edit, and proofread labeling documents; ensure consistent voice, style, and accuracy.
- Manage labeling changes through internal change control systems, maintaining version control and traceability from development through release and post-market phases.
- Coordinate localization, translation management, and proofing for global IFUs with internal teams and third-party vendors.
- Identify and implement new tools, templates, documentation methods, and procedures to improve efficiency.
**Marketing & Promotional Material Review**
- Serve as regulatory reviewer for marketing and clinical materials under management direction.
- 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 processes.
- 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.
**Requirements:**
- Bachelor's degree in life sciences, technical field, or related discipline.
- 5–7 years of experience as a technical writer.
- Proven experience drafting, updating, or reviewing technical documentation, labeling, or IFUs under regulatory frameworks (FDA, EU MDR, etc.).
- Hands-on experience with marketing-material review processes and evaluating commercial marketing content against approved indications/claims.
- High computer literacy with demonstrated proficiency in EDMS, PLM systems, databases, advanced Excel/data tools, and document collaboration platforms (Veeva, MasterControl, SharePoint, TrackWise, etc.).
- Excellent written and verbal communication skills with strong attention to detail, grammar, and technical drafting.
- 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.
- Hands-on experience with command-line tools, DOS/Batch scripting, and Java environments to support developer documentation and automated publishing build processes.
