Senior Technical Writer

Key Duties And 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.
• Create, Write, and Edit Labeling Materials: Develop and write 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).
• Maintain 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.
• Coordinate 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.

Job Specifications

• 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.
• 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.
• Physical Demands: Regularly sit and talk or hear. Occasionally stand and walk. Must lift and carry up to 50 pounds.