Engineering – Prin 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

Pay 50-60/h depending on experience

HM's Top Needs:

1. Medical Devices experience (minimum 6 years) creating artwork files using Adobe Illustrator and Indesign in technical communication/technical writing/ labeling development/content generation

2. SME knowledge of Instructions for use (IFU) and other labeling content requirements

3. Labeling Standards and Regulations expertise

   Education Required: Master's in regulatory or any engineering field.

   Years' Experience Required: minimum 6years

The Principal Technical Writer leads the development and lifecycle management of customer-facing medical devices labeling content and artwork for neurovascular medical devices, including Instructions for Use (IFUs), user guides, electronic labeling, and preprinted packaging materials. This role translates complex technical and regulatory information into clear, accurate, user-focused content for healthcare professionals, clinicians, and patients. Working across new product development and sustaining initiatives, the position ensures labeling deliverables meet global regulatory requirements, design control expectations, quality standards, and business objectives.

Key Responsibilities

• Labeling Development: Lead the end-to-end creation, revision, and optimization of IFUs, user guides, electronic labeling, and preprinted packaging artwork from concept through final release using Adobe Indesign, Illustrator, content management and other tools and technology.
• Content Strategy: Define documentation and artwork requirements, gather cross-functional inputs, and translate complex technical information into accurate, accessible content for technical and nontechnical users.
• Regulatory and Quality Compliance: Ensure labeling conforms to applicable global regulations and standards, including but not limited to FDA, EU MDR, IMDRF, UDI, IEC60601, ISO20417, ISO15223, as well as internal quality management system requirements.
• Cross-Functional Leadership: Partner with R&D, Regulatory Affairs, Quality, Marketing, Medical Safety, Clinical, and other stakeholders to align content, resolve issues, and deliver labeling milestones on schedule.
• Risk and Change Management: Assess compliance gaps and implementation risks, lead Change Orders and design control deliverables, and maintain substantiation, traceability, review, and verification documentation.
• Lifecycle Management: Support product launches, sustaining activities, and legacy document maintenance while driving standardization, version control, and compliant implementation across the labeling lifecycle.
• Regulatory Intelligence: Monitor evolving regulatory requirements and provide timely, practical guidance to project teams and leadership.