← All roles

Senior Regulatory Labeling Specialist

Heartflow· Regulatory Affairs
Apply on company site
San Francisco, CA, Rohnert Park, CA$145k - $168k + equity + bonusFull-timePosted yesterday

About the role

Senior Regulatory Labeling Specialist responsible for authoring and maintaining IFU and labeling, reviewing promotional materials, and leveraging IT systems to streamline regulatory documentation and submissions across global product lifecycle at Heartflow.

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 (e.g., ISO 15223, EU MDR/IVDR, FDA labeling regulations).
  • Collaborate with cross-functional teams to translate technical specs into clear, accurate, and compliant end-user instructions.
  • Write, copy edit, proofread documents related to product development and ensure documentation reflects a consistent voice and style
  • Manage labeling changes through the internal change control system, ensuring document version control and traceability, from development, release, and post-market.
  • Coordinate localization, translation management, and proofing process for global IFUs and other labeling internally and with 3rd party vendors.
  • Identify and implement new or improved tools, templates, documentation methods and procedures to maintain efficiency.
  • Under the direction of Management, serve as a regulatory reviewer for marketing and clinical materials
  • 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.
  • Support software release process
  • Utilize EDMS, eCTD publishing tools, and 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
  • 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.

Qualifications

  • 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 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 a strong eye for detail, grammar, and technical drafting.
  • Ability to manage multiple review requests and projects simultaneously under firm commercial deadlines.

Skills

Required:Technical WritingRegulatory LabelingMarketing Material ReviewEDMS / PLM Systems

Benefits

  • Not explicitly specified in the job description.
Last updated Oct 26, 2026. Interested? Apply on the company site.

About Heartflow

Decisive Coronary Care

Heartflow’s vision is to transform CAD from the leading cause of death into a disease that can be managed for life.

CCTA ResourcesRoadmap AnalysisFFRCT AnalysisPlaque AnalysisHeartflow OneHeartflow One PlatformMeasurable Impact
Company profileWebsite

More open roles at Heartflow