Senior Technical Writer

CQ Medical Careers•Virtual, NJ

About The Position

Responsible for creating clear, accurate, and compliant labeling materials such as product labels, instructions for use (IFUs), and packaging inserts. They ensure adherence to global regulatory standards (e.g., FDA, EU MDR), collaborate with cross-functional teams (e.g., regulatory, engineering, marketing, PLM, quality), and manage the review and approval processes. Additionally, they manage labeling documentation, track revisions, and continuously improve labeling processes to ensure quality, safety, and regulatory compliance.

Requirements

Associate's degree (A. A.) or equivalent from two-year college or technical school and four years of related experience and/or training; or equivalent combination of education and experience with technical writing in the medical device sector.
Attention to Detail — Job requires being careful about detail and thorough in completing work tasks.
The ability to communicate information and ideas in writing so others will understand.
The ability to listen to and understand information and ideas presented through spoken words and sentences.
The ability to see details at close range (within a few feet of the observer).
The ability to speak clearly so others can understand you.
Keeping up-to-date technically and applying new knowledge to your job.
The ability to provide training and information about the safety and proper operation of equipment and systems.
The ability to read and understands written instructions.
Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Computer skills to include proficiency in Microsoft Office software and Adobe InDesign, Photoshop and Illustrator.

Nice To Haves

Knowledge of MadCap Software programs desired, but not required.

Responsibilities

Ensure labeling content complies with global regulatory requirements (e.g., FDA, EU MDR, ISO 13485, etc.) and meets local language and format standards.
Stay informed about changes to relevant medical device regulations and standards and ensure that the labeling documentation reflects these changes.
Work closely with regulatory affairs, legal, and quality assurance teams to verify that labels and instructions for use meet all legal and regulatory obligations.
Create, write, and edit high-quality, clear, concise, and accurate labeling materials for medical devices, including product labels, user manuals, instruction guides, and packaging inserts.
Translate complex technical information into user-friendly language that is easily understandable for target audiences (e.g., healthcare professionals, patients).
Maintain consistent terminology, style, and format across all documentation, ensuring alignment with company guidelines and industry standards.
Work with product development, engineering, and design teams to understand product specifications, functionality, and key messages that should be included in the labeling.
Coordinate with marketing and clinical teams to ensure that the labeling conveys accurate and appropriate product trademarking and branding.
Lead and coordinate the review and approval process for labeling materials, ensuring that all internal stakeholders (e.g., regulatory, engineering, marketing, PLM, quality) have reviewed and signed off.
Maintain and track revisions to ensure accurate and timely updates to labeling materials, ensuring that version control is in place.
Participate in risk management activities, such as reviewing the impact of labeling on patient safety, usability, and device performance.
Ensure that all labeling materials meet high-quality standards, including error-free content, appropriate visual design, and accurate information.
Manage multiple labeling projects simultaneously, ensuring that deadlines are met, and quality standards are maintained.
Maintain schedules for labeling tasks and deliverables, ensuring coordination with product development timelines and launch dates.
Continuously evaluate and improve labeling processes to increase efficiency, accuracy, and compliance with regulatory standards.