ATR ID:

ATR226559

Job Title:

Engineering - Prin Technical Writer - Exempt

Job Level:

Technical Writers/Editors

Duration:

24 months

Location:

Irvine

CA 92617

Education:

Master's in regulatory or any engineering field.

Email:

Nguyen, Jonathan

Phone:

408-899-3965

Pay rate:

$51.96 - $63.50 (Hourly)

Benefits:

• Benefits
• Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws. Compensation
• Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select. Work Authorization

ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization. ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees. 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.

Requirement:

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 6 years How to

Apply:

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