Technical Writer - Onsite

About the role

A Day in the Life Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey.

Responsibilities

• Create plans to support document release activities from start to end.
• Identify IFU/labeling requirements and obtain necessary content information from various sources.
• Learn and understand the design and behavior of the company’s products.
• Design, develop, and maintain IFU/labeling using Adobe InDesign and other software applications.
• Control IFU/labeling versioning and maintain the IFU archives.
• Identify IFU/labeling translation requirements, prepare and manage translation projects to completion.
• Manage change control and perform the administrative documentation tasks required to establish and track IFU/labeling in a Product Lifecycle Management system.
• Understand and apply relevant US and EU regulations, standards, and guidance documents (e.g., 21 CFR, EU MDR, IMDRF, ISO20417, ISO15223, and ISO 10555), as well as Medical Device Quality Systems (e.g., ISO 13485) and Risk tools (e.g., ISO 14971).
• Continuously evaluate business processes, identify improvement opportunities, and implement improvements.
• Perform quality checks and proofread the artworks.

Requirements

Requires a Baccalaureate degreeMinimum of 2 years of regulatory/product compliance, labeling, technical writing, or technical editing experience in the medical devices industry.

Qualifications

Nice To Have: Advanced experience with Structured Authoring using XML and content management solutions(CMS).Advanced Experience with Adobe Acrobat® and PhotoShop® software, vector graphics software (e.g. Adobe Illustrator®) and HTML.Experience writing for a global audience.Experience with CMS

Skills

Advanced experience with Structured Authoring using XML and content management solutions(CMS).Advanced Experience with Adobe Acrobat® and PhotoShop® software, vector graphics software (e.g. Adobe Illustrator®) and HTML.Experience writing for a global audience.Experience with CMS

Benefits

Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

Pay

USD 68k-102k / year + Equity

Schedule

Minimum of 4 days a week onsite