HeartFlow
Senior Regulatory Labeling Specialist
$145K–$168K
San Francisco, California +3 · Senior · Full-time · Posted Oct 19, 2026
- Location
- San Francisco, California
Rohnert Park, California
Rohnert Park, California, United States
San Francisco - Experience
- 5–7 years of experience as a technical writer.
- Education
- Bachelor’s degree in life sciences, technical field, or a related discipline.
About the job
Develops and maintains regulated product labeling and Instructions for Use, reviews promotional materials for compliance, and supports regulatory documentation systems and submissions.
What you'll do
- Draft, update, and manage IFUs and other product labeling, including change control and global localization.
- Review marketing and clinical materials for substantiated claims consistent with approved product indications.
- Manage regulatory assets and databases, support software releases and submissions, and assist with audits and post-market compliance.
What they ask for
- Bachelor’s degree in life sciences, a technical field, or a related discipline.
- Proven experience drafting, updating, or reviewing technical documentation, labeling, or IFUs under regulatory frameworks such as FDA or EU MDR.
- Hands-on experience reviewing marketing materials against approved indications and claims.
- Proficiency with EDMS, PLM systems, databases, advanced Excel/data tools, and document collaboration platforms.
Nice to have
- Familiarity with XML, structured authoring tools, or translation management systems; experience with UDI registration procedures.
- Experience with MadCap Flare, command-line tools, DOS/Batch scripting, or Java environments.
Pay
USD $145,000 - $168,000 base salary
Tools
ISO 15223, EU MDR/IVDR, FDA, MasterControl, Veeva, Arena, FDA GUDID, EUDAMED
Model-written summary · the original posting is authoritative