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New · posted Oct 20

HeartFlow · Medical Devices

Senior Regulatory Labeling Specialist

  • San Francisco, CA +1 more
  • On-site
  • Full-time
  • Senior & Principal
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Pay$145K–$168Ka year · employer provided
EmploymentFull-time
LocationSan Francisco, CA +1 moreOn-site
LevelSenior & Principal
FunctionLabeling & PromotionRegulatory
Deadline

Open until filled

The role

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 FFRCT Analysis—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 (FFRCT Analysis), 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.

What you need

  • 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 Qualificationsnice to have

  • 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.

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 www.heartflow.com/about/careers/.

Skills named in this posting

What you'll do

Labeling & Instructions for Use (IFU) Development

  1. 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).
  2. Collaborate with cross-functional teams (Product, Engineering, Clinical, and Medical Affairs) to translate technical specs into clear, accurate, and compliant end-user instructions.
  3. Write, copy edit, proofread documents related to the product development and ensure documentation reflects a consistent voice and style
  4. Manage labeling changes through the internal change control system, ensuring document version control and traceability, from development, release, and post-market.
  5. Coordinate localization, translation management, and proofing process for global IFUs and other labeling internally and with 3rd party vendors.
  6. Identify and implement new or improved tools, templates, documentation methods and procedures to maintain efficiency.

Marketing & Promotional Material Review

  1. Under the direction of Management, serve as a regulatory reviewer for marketing  and clinical materials
  2. 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.
  3. Mitigate regulatory exposure by identifying off-label claims or unverified promotional statements and proposing compliant alternative wording.

Systems, IT, and Data Management

  1. Support software release process
  2. 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.
  3. Maintain and populate internal and external regulatory databases, tracking systems, and global product registration databases (e.g., FDA GUDID, EUDAMED).
  4. Optimize workflows to enhance cross-departmental regulatory efficiency.

General Regulatory & Compliance Support

  1. Assist with compiling, formatting, and organizing regulatory submissions (e.g., 510(k), STED, CE mark technical files).
  2. Monitor changing regulatory requirements, guidance documents, and industry standards related to labeling and promotional activities.
  3. Assist in regulatory audits, inspections, and post-market compliance initiatives as required.

Pay and benefits

$145,000 – $168,000 a year

Employer provided
How this compares

This position has an estimated base salary of $145,000 - $168,000, bonus, and equity.

  • Bonus

  • Equity

Where you'll work

San Francisco, CA +1 moreOn-siteOpen in Maps (opens in a new tab)

Also posted for: Rohnert Park, CA

More jobs in San Francisco, CA +1 more
Equal opportunity, accessibility and legal noticesHeartFlow's statements, word for word

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.

Job intelligence

The context around this role

Live data · October 20, 2026

Salary intelligence

How the pay compares

This role's midpoint is level with the US median for Labeling & Promotion roles at this level.

This roleEmployer provided

$145,000 to $168,000 a year

Senior & Principal roles in the US5 roles publishing pay

Middle half $111,000 to $176,500, median $156,500
Annual base pay
Annual base payLowMedianHigh
This role$145,000—$168,000
All US$111,000$156,500$176,500

This role: HeartFlow's own published range. Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Labeling & Promotion

The general path across 79 open Labeling & Promotion roles on Regulatory Jobs, with the titles they carry most. Not HeartFlow's own promotion track.

  1. One step back

    Associate & Specialist

    Often: 2027 Future Talent Program · Engineer

    $81K median8 open

  2. This role

    Senior & Principal

    Often: Senior / Global Regulatory Labeling Strategist · Senior Regulatory Strategist, Advertising & Promotion

    $157K median9 open

  3. Next step

    Manager

    Often: Manager, Regulatory Affairs, Advertising & Promotion · Regulatory Affairs Manager

    $150K median21 open

  4. Later

    Director

    Often: Associate Director, Regulatory Affairs Advertising & Promotion · Associate Director, Regulatory Affairs US Advertising and Promotion

    $206K median36 open

  5. Later

    VP & Executive

    Often: Head of Global Labelling · Head of Global Regulatory Advertising and Promotion

    5 open

Skills DNA

What this role leans on

How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 3 linesLab testing and methods: 2 linesDocumentation and SOPs: 11 linesRegulatory submissions: 7 linesQuality systems and risk: 1 lineData and digital systems: 5 linesCollaboration and leadership: 6 linesGMPLab testingDocumentationSubmissionsQuality systemsData systemsTeamwork
  • Documentation and SOPs11
  • Regulatory submissions7
  • Collaboration and leadership6
  • Data and digital systems5
  • GMP and compliance3
  • Lab testing and methods2
  • Quality systems and risk1

Regulatory intelligence

The rules behind this role

Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

HeartFlow on Regulatory Jobs

6
Open roles
6
Distinct roles
1
Locations

By discipline

  • Quality3 50%
  • Regulatory2 33%
  • Compliance & Safety1 17%

By level

  • Senior & Principal4 67%
  • Director1 17%
  • Manager1 17%
See all 6 HeartFlow roles

More roles at HeartFlow

All 6 HeartFlow roles

Similar Labeling & Promotion roles elsewhere

Senior Regulatory Labeling Specialist at HeartFlow

Open until filled. $145K–$168K a year, employer provided.

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