Senior Regulatory Labeling Specialist

Heartflow•Rohnert Park, CA

3h•$145,000 - $168,000

About The Position

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease through AI-driven, non-invasive cardiac testing. The Senior Regulatory Labeling Specialist supports global product lifecycle management by ensuring compliance across core regulatory functions, with a particular focus on authoring and maintaining Instructions for Use (IFUs) and other labeling, reviewing promotional and marketing materials, and using digital systems to manage documentation and submissions. The role connects technical writing and regulatory compliance with cross-functional collaboration involving Product, Marketing, Engineering, Clinical, and Medical Affairs. The specialist leads or supports the creation, drafting, and maintenance of IFUs, product inserts, user manuals, and technical labeling; coordinates labeling changes and global localization; and reviews commercial materials for regulatory compliance. The position also supports software releases, regulatory databases and submissions, audits, inspections, and post-market compliance activities.

Requirements

Bachelor’s degree in life sciences, a technical field, or a 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 such as FDA regulations or EU MDR.
Hands-on experience reviewing marketing materials and evaluating commercial content against approved indications and claims.
High computer literacy and demonstrated proficiency with EDMS, PLM systems, databases, advanced Excel or data tools, and document collaboration platforms.
Excellent written and verbal communication skills, attention to detail, grammar, and technical drafting.
Ability to manage multiple review requests and projects simultaneously under firm commercial deadlines.

Nice To Haves

Familiarity with XML, structured authoring tools, or translation management systems for global IFUs.
Experience with UDI registration procedures, including GUDID and 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.

Responsibilities

Lead or support creation, drafting, and maintenance of IFUs, product inserts, user manuals, and technical labeling in compliance with applicable standards and regulations.
Collaborate with Product, Engineering, Clinical, and Medical Affairs teams to turn technical specifications into clear, accurate, compliant instructions for end users.
Write, copy edit, and proofread product-development documents, maintaining consistent voice and style.
Manage labeling changes through the internal change control system, ensuring version control and traceability from development through release and post-market activity.
Coordinate localization, translation management, and proofing of global IFUs and other labeling, working with internal teams and third-party vendors.
Identify and implement tools, templates, documentation methods, and procedures to improve efficiency.
Review marketing and clinical materials under management direction.
Evaluate advertising, commercial collateral, website copy, digital campaigns, and social media content for substantiated, fair-balanced claims aligned with approved product indications.
Identify off-label claims or unverified promotional statements and propose compliant alternative wording.
Support the software release process.
Use EDMS, eCTD publishing tools, and PLM software to archive and manage regulatory assets.
Maintain and populate internal and external regulatory databases, tracking systems, and global product registration databases such as FDA GUDID and EUDAMED.
Optimize workflows to improve cross-departmental regulatory efficiency.
Assist with compiling, formatting, and organizing regulatory submissions, including 510(k), STED, and CE mark technical files.
Monitor regulatory requirements, guidance documents, and industry standards related to labeling and promotional activities.
Assist with regulatory audits, inspections, and post-market compliance initiatives as required.