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About the Role
As a Senior Regulatory Labeling Specialist at Heartflow, you will ensure compliance across core regulatory functions, focusing on authoring and maintaining Instructions for Use (IFU) and other labeling, conducting regulatory reviews of promotional materials, and leveraging IT systems to streamline documentation and submissions. This role serves as a bridge between engineering innovations and global users, supporting product lifecycle management.
Responsibilities
- 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.
- Collaborate with cross-functional teams to translate technical specifications into clear, accurate, and compliant end-user instructions.
- Write, copy edit, and proofread documents related to product development, ensuring consistent voice and style.
- Manage labeling changes through the internal change control system, ensuring document version control and traceability.
- Coordinate localization, translation management, and proofing processes for global IFUs and other labeling.
- Identify and implement new or improved tools, templates, documentation methods, and procedures to maintain efficiency.
- Serve as a regulatory reviewer for marketing and clinical materials under management direction.
- Evaluate advertising, commercial collateral, website copy, digital campaigns, and social media content for substantiated claims and fair balance.
- Mitigate regulatory exposure by identifying off-label claims or unverified promotional statements and proposing compliant alternatives.
- Support the software release process.
- Utilize Electronic Document Management Systems (EDMS), Electronic Common Technical Document (eCTD) publishing tools, and Product Lifecycle Management (PLM) software to archive and manage regulatory assets.
- Maintain and populate internal and external regulatory databases, tracking systems, and global product registration databases.
- Optimize workflows to enhance cross-departmental regulatory efficiency.
- Assist with compiling, formatting, and organizing regulatory submissions.
- 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.
Requirements
- Bachelor’s degree in life sciences, 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 (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.
- Excellent written and verbal communication skills with a strong eye for detail, grammar, and technical drafting.
- Ability to manage multiple review requests and projects simultaneously under firm commercial deadlines.
- 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.
Skills
- Technical Writing
- Regulatory Compliance
- Labeling
- Instructions for Use (IFU)
- Marketing Material Review
- EDMS
- PLM Software
- Databases
- Excel
- Document Collaboration Platforms
- Communication
- Project Management
- XML
- Structured Authoring
- Translation Management Systems
- UDI Registration
- MadCap Flare
- Command-line tools
- DOS/Batch scripting
- Java environments
Location
- Remote
Work Type
- Full-time
Experience Level
- Senior
Education Level
- Bachelor's degree
Salary/Compensations
- $145,000 - $168,000
Benefits
- Bonus
- Equity
About the Company
- Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using AI-driven, non-invasive cardiac testing.
- The flagship product, Heartflow FFRCT Analysis, provides a 3D model of coronary arteries indicating the impact of blockages on blood flow.
- Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway.
- Heartflow is a publicly traded company (HTFL) recognized for healthcare innovation.
- The product is cleared for use in the US, UK, Europe, Japan, and Canada and has been used for over 750,000 patients worldwide.
- Heartflow is revolutionizing cardiovascular care through precision technology.
Equal Opportunity
- Heartflow is an Equal Opportunity Employer.
- We are committed to a work environment that supports, inspires, and respects all individuals.
- We 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.