Note: The job is a remote job and is open to candidates in USA. CQ Medical is seeking a Senior Technical Writer responsible for creating clear and compliant labeling materials for medical devices. The role involves ensuring adherence to global regulatory standards, collaborating with various teams, and managing the review and approval process for labeling documentation.
Responsibilities
- Ensure Compliance: Ensure labeling content complies with global regulatory requirements (e.g., FDA, EU MDR, ISO 13485, etc.) and meets local language and format standards
- Stay Updated on Regulatory Changes: Stay informed about changes to relevant medical device regulations and standards and ensure that the labeling documentation reflects these changes
- Collaborate with Regulatory Affairs and Legal Teams: Work closely with regulatory affairs, legal, and quality assurance teams to verify that labels and instructions for use meet all legal and regulatory obligations
- Develop and Write Labeling Content: 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
- Simplify Complex Information: Translate complex technical information into user-friendly language that is easily understandable for target audiences (e.g., healthcare professionals, patients)
- Ensure Consistency: Maintain consistent terminology, style, and format across all documentation, ensuring alignment with company guidelines and industry standards
- Collaborate with Design and Engineering Teams: Work with product development, engineering, and design teams to understand product specifications, functionality, and key messages that should be included in the labeling
- Work with Marketing and Clinical Teams: Coordinate with marketing and clinical teams to ensure that the labeling conveys accurate and appropriate product trademarking and branding
- Manage Review Cycles: 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
- Track Changes: Maintain and track revisions to ensure accurate and timely updates to labeling materials, ensuring that version control is in place
- Identify and Address Risks: Participate in risk management activities, such as reviewing the impact of labeling on patient safety, usability, and device performance
- Quality Control: Ensure that all labeling materials meet high-quality standards, including error-free content, appropriate visual design, and accurate information
- Lead Labeling Projects: Manage multiple labeling projects simultaneously, ensuring that deadlines are met, and quality standards are maintained
- Track Milestones and Deliverables: Maintain schedules for labeling tasks and deliverables, ensuring coordination with product development timelines and launch dates
- Evaluate and Improve Processes: Continuously evaluate and improve labeling processes to increase efficiency, accuracy, and compliance with regulatory standards
Skills
- 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
- Knowledge of MadCap Software programs desired, but not required
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