Senior Technical Writer

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.