Senior Regulatory Labeling Specialist
About The Position
Heartflow is a medical technology company focused on advancing the diagnosis and management of coronary artery disease with AI-driven, non-invasive cardiac technology. Its products support clinicians in identifying coronary stenoses, assessing coronary blood flow, and characterizing coronary atherosclerosis. The Senior Regulatory Labeling Specialist will support global product lifecycle management by connecting technical product information with clear, compliant documentation for clinicians and patients. The role focuses on authoring and maintaining Instructions for Use (IFUs) and other labeling, reviewing promotional and marketing materials for regulatory compliance, and using digital systems and databases to manage documentation and submissions. The specialist collaborates across Product, Engineering, Clinical, Medical Affairs, and Marketing, and supports regulatory compliance activities, including submissions, audits, and post-market initiatives.
Requirements
- Bachelor’s degree in life sciences, a technical field, or a related discipline.
- 5–7 years of experience as a technical writer.
- Demonstrated experience drafting, updating, or reviewing technical documentation, labeling, or IFUs under regulatory frameworks such as FDA and EU MDR.
- Hands-on experience with marketing-material review processes and evaluating commercial content against approved indications and claims.
- High computer literacy and demonstrated proficiency with EDMS, PLM systems, databases, advanced Excel/data tools, and document collaboration platforms such as Veeva, MasterControl, SharePoint, or TrackWise.
- Excellent written and verbal communication skills, attention to detail, grammar, and technical drafting skills.
- 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 the creation, drafting, and maintenance of IFUs, product inserts, user manuals, and technical labeling in compliance with applicable standards and regulations, including ISO 15223, EU MDR/IVDR, and FDA labeling regulations.
- Collaborate with Product, Engineering, Clinical, and Medical Affairs to turn technical specifications into clear, accurate, compliant end-user instructions.
- Write, copy edit, and proofread product-development documents, ensuring consistent voice and style.
- Manage labeling changes through the internal change-control system, maintaining version control and traceability from development through release and post-market activities.
- Coordinate localization, translation management, and proofing for global IFUs and other labeling, working internally and with third-party vendors.
- Identify and implement improved tools, templates, documentation methods, and procedures to improve efficiency.
- Under management direction, review marketing and clinical materials for regulatory compliance.
- 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.
- 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, including 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 changing 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.
Benefits
- Bonus
- Equity
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What This Job Offers
Job Type
Full-time
Career Level
Senior
