Heartflow

Heartflow

Senior Regulatory Labeling Specialist

San Francisco, California; Rohnert Park, California · Senior

Sponsorship not specified$145k-$168kDetected 3 days ago
JavaComplianceProduct ManagementProject ManagementExcelFDA RegulatoryMedical DevicesCommunicationCollaborationWritingSharePoint

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odds of building a lasting career here

54Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

3 transfer filings in the last year, covering 3 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About 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.
  • Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.

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).
  • Write, copy edit, proofread documents related to the 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.
  • Identify and implement new or improved tools, templates, documentation methods and procedures to maintain efficiency.
  • Support software release process
  • 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.
  • 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.
  • General Regulatory & Compliance Support
  • Monitor changing regulatory requirements, guidance documents, and industry standards related to labeling and promotional activities.

Requirements

  • 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.).
  • 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.).
  • Assist in regulatory audits, inspections, and post-market compliance initiatives as required.
  • Marketing Review: Hands-on experience with marketing-material review processes and evaluating commercial marketing content against approved indications/claims.

Nice 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 is an Equal Opportunity Employer.
  • 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.

Compensation

  • This position has an estimated base salary of $145,000 - $168,000, bonus, and equity. #LI-IB1

Benefits

  • Collaborate with cross-functional teams (Product, Engineering, Clinical, and Medical Affairs) to translate technical specs into clear, accurate, and compliant end-user instructions.
  • Education: Bachelor's degree in life sciences, technical field, or a related discipline.

Company info

  • At Heartflow, we are revolutionizing cardiovascular care through precision technology.
  • 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.
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This listing is sourced directly from Heartflow's careers page and normalized into a canonical job model.