Senior Regulatory Labeling Specialist - IFU & Compliance

Regulatory Jobs; San Francisco (CA); On-site; USD 145,000 - 168,000; Full time

Job summary

Heartflow is seeking a Senior Regulatory Labeling Specialist to bridge engineering innovation and patient care. You’ll author and maintain Instructions for Use and labeling, review marketing materials for regulatory compliance, and use EDMS/PLM systems to streamline submissions globally.

Ideal candidates bring 5–7 years as a technical writer, labeling expertise under FDA/EU MDR, and strong collaboration with Product, Engineering, and Medical Affairs. Remote options are not specified.

Qualifications

• Education: Bachelor’s degree in life sciences or related field.
• Experience: 5–7 years as a technical writer.
• Labeling Expertise: Drafting/updating/reviewing labeling under FDA/EU MDR.
• Marketing Review: Review marketing content against approved indications.
• IT & Systems Proficiency: Proficient in EDMS, PLM, databases and Excel.
• Communication: Excellent written and verbal communication with attention to detail.
• Project Management: Manage multiple reviews under tight deadlines.

Responsibilities

• Lead creation and maintenance of IFUs, product labeling and user manuals.
• Collaborate with Product, Engineering, Clinical, and Medical Affairs to translate specs for end users.
• Write, edit, proofread documents to ensure consistency and compliance.
• Manage labeling changes with change control, versioning and traceability.
• Coordinate localization and translation for global IFUs with vendors.
• Support regulatory reviews of marketing materials and digital content.
• Assist with regulatory submissions and audits as needed.
• Maintain regulatory databases and archive regulatory assets.

Skills

Technical writing

Regulatory labeling

Cross-functional collaboration

Documentation proofreading

Education

Bachelor's degree in life sciences

Tools

EDMS

PLM systems

Veeva

MasterControl

SharePoint

TrackWise

Excel

Job description

Heartflow is seeking a Senior Regulatory Labeling Specialist to bridge engineering innovation and patient care. You’ll author and maintain Instructions for Use and labeling, review marketing materials for regulatory compliance, and use EDMS/PLM systems to streamline submissions globally.

Ideal candidates bring 5–7 years as a technical writer, labeling expertise under FDA/EU MDR, and strong collaboration with Product, Engineering, and Medical Affairs. Remote options are not specified.