Principal Technical Writer

Principal Technical Writer

Job Details

Posted 28 September, 2026

Job Id: 631261

Engineering – Prin Technical Writer

Location

Irvine, CA

Category: Regulatory Affairs

Salary

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Country: United States

Employment: Contract

Worksite: On-Site

Job Description

Pay 50-60/h depending on experience

HM’s Top Needs:

• Medical Devices experience (minimum 6 years) creating artwork files using Adobe Illustrator and Indesign in technical communication/technical writing/ labeling development/content generation
• SME knowledge of Instructions for use (IFU) and other labeling content requirements
• Labeling Standards and Regulations expertise

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

Years’ Experience Required: minimum 6 years

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.

• Equal Opportunity Employer

• We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.