Senior Regulatory Labeling Specialist

The role

The Senior Regulatory Labeling Specialist will author and maintain Instructions for Use and technical labeling. This role involves reviewing marketing materials for regulatory compliance and managing documentation through IT systems and databases.

What you will do

• Lead or support the creation, drafting, and maintenance of Instructions for Use, product inserts, user manuals, and technical labeling.
• Collaborate with cross-functional teams to translate technical specs into compliant end-user instructions.
• Write, copy edit, and proofread product development documents.
• Manage labeling changes through the internal change control system.
• Coordinate localization and translation management for global IFUs.
• Identify and implement new tools, templates, and documentation methods.
• Serve as a regulatory reviewer for marketing and clinical materials.
• Evaluate advertising, website copy, and digital campaigns to ensure claims are substantiated.
• Support software release process.
• Utilize EDMS, eCTD, and PLM software to manage regulatory assets.

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.
• Hands-on experience with marketing-material review processes.
• High computer literacy with proficiency in EDMS, PLM systems, databases, advanced Excel/data tools, and document collaboration platforms.
• Excellent written and verbal communication skills.
• Ability to manage multiple review requests and projects simultaneously under firm commercial deadlines.

Nice to have

• Familiarity with XML, structured authoring tools, or translation management systems.
• 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.

Benefits

• bonus
• equity

About the company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology. It is a publicly traded company that provides an AI-driven, non-invasive cardiac test.