Senior Technical Writer
New
Based in the United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- Four years of related experience and/or training
- Required Skills
- Adobe IllustratorAdobe InDesignAdobe PhotoshopMicrosoft Office
Requirements
- Associate degree or equivalent from a two-year college or technical school, combined with four years of related experience and/or training.
- Professional experience in technical writing within the medical device industry or another highly regulated sector.
- Strong understanding of documentation practices, labeling requirements, and regulatory compliance standards.
- Exceptional written communication skills with excellent grammar, editing, and content organization abilities.
- Ability to interpret complex technical information and communicate it clearly to technical and non-technical audiences.
- Strong attention to detail with a commitment to accuracy, quality, and compliance.
- Experience collaborating with cross-functional teams including engineering, regulatory, quality, and marketing stakeholders.
- Ability to manage multiple projects, deadlines, and changing priorities effectively.
- Proficiency with Microsoft Office applications.
- Experience with Adobe InDesign, Photoshop, and Illustrator.
Responsibilities
- Create, write, edit, and maintain high-quality labeling materials, including product labels, instructions for use (IFUs), user manuals, technical guides, and packaging inserts.
- Ensure all documentation complies with global regulatory requirements, including FDA, EU MDR, ISO 13485, and applicable regional standards.
- Partner with regulatory affairs, quality assurance, engineering, legal, marketing, and clinical teams to validate technical accuracy and compliance.
- Translate complex technical information into clear, concise, and user-friendly content for healthcare professionals and end users.
- Manage labeling review and approval cycles, coordinating feedback and approvals from key stakeholders.
- Track revisions, maintain document history, and ensure proper version control throughout the documentation lifecycle.
- Support risk management activities by reviewing documentation impacts related to safety, usability, and product performance.
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