Senior Technical Writer - Labeling content and artwork development ( Medical Devices) - On-site
MedTechPharmaRegulatory AffairsQuality Assuranceheorregulatory submissionemafdamdrcrorave
Job description
We anticipate the application window for this opening will close on - 26 Sep 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. 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. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. <p style="text-align:inherit"
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