Senior Technical Writer - Labeling content and artwork development (Medical Devices) - On-site

A Day in the Life

The Neurovascular Operating Unit develops technologies that enable the treatment of acute ischemic stroke, hemorrhagic stroke, and other neurovascular conditions. The team partners across Research and Development, Regulatory Affairs, Quality, Clinical, Manufacturing, and Marketing to deliver products that support physicians and improve patient outcomes. This role is based in Irvine, California and follows an onsite work arrangement. The position supports labeling content and artwork development activities for medical devices throughout the product lifecycle, from new product development through sustaining engineering and change management. No travel is required for this position.

The Sr. Technical Writer - Labeling Content and Artwork Development is responsible for developing, maintaining, and managing labeling content for neurovascular medical devices. This role partners with cross-functional stakeholders to create clear, accurate, and compliant labeling documentation and artwork content that meets regulatory, quality, and business requirements. The position requires translating complex technical information into user-focused content while supporting labeling changes, product launches, and design control activities.

Primary Responsibilities

• Develop, write, review, and maintain medical device labeling content, including Instructions for Use (IFUs), product labels, package inserts, and related documentation.
• Partner with Regulatory Affairs, Quality, Research and Development, Clinical, and Marketing teams to gather information and ensure labeling accuracy and compliance.
• Create and manage artwork content for labeling components in accordance with established design control and document control processes.
• Conduct interviews and information-gathering sessions with subject matter experts to obtain technical and product-specific content.
• Translate complex scientific, engineering, and clinical information into clear documentation for healthcare professionals and other intended users.
• Support labeling updates associated with product changes, regulatory submissions, post-market activities, and continuous improvement initiatives.
• Ensure documentation and artwork content comply with applicable quality system requirements, regulatory standards, and internal documentation procedures.
• Participate in document reviews, change control activities, and approval workflows to support timely product development and release objectives.

Required Qualifications

• Bachelor's degree and a minimum of 4 years of relevant technical writing, labeling, documentation, or regulated-industry experience; or an advanced degree with a minimum of 2 years of relevant experience.
• Minimum of 2 years of experience developing technical documentation, labeling content, or user-facing documentation within a regulated environment.
• Experience collaborating with cross-functional stakeholders to develop and manage controlled documentation.
• Translating complex technical information into clear written content for technical and nontechnical audiences.
• Experience using document management systems, document control processes, or quality-controlled documentation workflows.

Preferred Qualifications

• Experience developing labeling content and artwork for medical devices.
• Experience working within the FDA, European Union Medical Device Regulation (EU MDR), or other global medical device regulatory frameworks.
• Knowledge of medical device design control, change management, and product lifecycle processes.
• Experience supporting neurovascular, cardiovascular, or other implantable and interventional medical device products.
• Experience working with artwork management, labeling systems, or electronic quality management systems.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.