Technical Writer – Medical Device Labeling Location: North Haven, CT (Preferred) | Lafayette, CO | Mounds View, MN Experience: 5–10 years Industry: Medical Devices Job Description: We are looking for an experienced Technical Writer / Medical Device Labeling Specialist to support labeling development and updates for medical device products within a regulated environment. The ideal candidate will have strong technical writing skills, experience creating and revising Instructions for Use (IFUs), and knowledge of regulatory compliance and quality management processes. Key Responsibilities: Develop, review, and update medical device labeling, including Instructions for Use (IFUs), in collaboration with cross-functional teams. Ensure labeling documentation meets applicable regulatory requirements, quality standards, and internal business processes. Manage multiple labeling updates and support new product introduction projects. Use authoring tools such as Adobe InDesign, FrameMaker, and XML-based tools to create and maintain technical documentation. Coordinate labeling approvals through Product Lifecycle Management (PLM) systems and manage Engineering Change Orders (ECOs). Coordinate translation requests, track translation status, and support labeling release activities. Review print proofs and support electronic and hardcopy labeling distribution, including metadata requirements. Gather technical information from engineering teams, product experts, and end users to develop accurate documentation. Support CAPA documentation, quality audits, regulatory submissions, and departmental initiatives. Collaborate with regulatory, quality, engineering, and product teams to support product launches. Required Qualifications: 5–10 years of experience in technical writing, medical device labeling, or technical documentation within a regulated industry. Experience developing and maintaining Instructions for Use (IFUs) or medical device product labeling. Familiarity with regulatory requirements, quality management systems, and controlled documentation processes. Experience with one or more authoring tools, such as Adobe InDesign, FrameMaker, or XML-based authoring tools. Strong written and verbal communication, technical writing, and cross-functional collaboration skills. Experience managing documentation updates, approvals, and multiple project deliverables. Preferred Qualifications: Experience in the medical device or surgical products industry. Familiarity with PLM systems, Engineering Change Orders (ECOs), and document change control. Experience coordinating translations, reviewing print proofs, and supporting product commercialization. Exposure to CAPA processes, quality audits, and regulatory submission documentation. Important Work Arrangement Requirement: This position requires onsite work four days per week and remote work one day per week . North Haven, CT is the preferred location, with Lafayette, CO, and Mounds View, MN, also considered. Candidates should be able to commute to their applicable location, preferably within one hour. Qualified candidates who meet the technical requirements and onsite expectations are encouraged to apply.