Senior Medical Devices Labeling & Technical Writer

Planet Pharma; Irvine (CA); On-site; USD 69,000 - 83,000; Full time

Job summary

Planet Pharma in Irvine, CA seeks a Principal Technical Writer to lead labeling content and artwork for neurovascular medical devices, including IFU, user guides, electronic labeling, and packaging materials.

The role translates complex regulatory information into clear content for healthcare professionals and patients, ensuring compliance with FDA, EU MDR, IMDRF, UDI, and ISO standards across product lifecycles.

Qualifications

• Minimum 6 years in medical devices labeling/content development.
• Expertise in Instructions for Use (IFU) labeling content.
• Knowledge of labeling standards and global regulatory requirements.
• Experience creating artwork files using Illustrator and InDesign.

Responsibilities

• Lead end-to-end IFUs, user guides, electronic labeling, and packaging artwork.
• Define documentation requirements and translate technical information for users.
• Ensure labeling compliance with FDA, EU MDR, IMDRF, UDI, ISO standards.
• Collaborate with R&D, Regulatory, Quality, Marketing, and other stakeholders.
• Assess risks, manage change orders and maintain documentation.
• Support product lifecycle labeling deliverables and version control.
• Monitor regulatory changes and advise project teams.

Skills

Medical devices experience

Adobe Illustrator

Adobe InDesign

Labeling development/content

IFU knowledge

Regulatory labeling standards

Education

Master's degree in regulatory or engineering

Tools

Adobe Illustrator

Adobe InDesign

Job description

Planet Pharma in Irvine, CA seeks a Principal Technical Writer to lead labeling content and artwork for neurovascular medical devices, including IFU, user guides, electronic labeling, and packaging materials.

The role translates complex regulatory information into clear content for healthcare professionals and patients, ensuring compliance with FDA, EU MDR, IMDRF, UDI, and ISO standards across product lifecycles.