Senior Technical Writer

Accountabilities

• 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.
• Maintain consistency in terminology, formatting, style, and documentation standards across all materials.
• 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.
• Identify opportunities to improve documentation processes, workflows, and efficiency.
• Support training materials and communication resources related to product operation and safety.

Requirements

• An experienced technical writing professional with expertise in regulated environments, particularly medical devices or related industries.
• Excellent communication skills, strong organizational abilities, and the capacity to transform complex technical information into accessible documentation.
• 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.
• Able to manage multiple projects, deadlines, and changing priorities effectively.
• Proficiency with Microsoft Office applications.
• Experience with Adobe InDesign, Photoshop, and Illustrator.
• Familiarity with MadCap software tools is a plus.
• Strong ability to understand technical instructions, procedures, and product information.
• Good verbal communication skills and the ability to support training and knowledge-sharing activities.

Benefits

• Opportunity to work on impactful documentation projects within a regulated healthcare technology environment.
• Collaborative role partnering with multidisciplinary teams across product, engineering, regulatory, and quality functions.
• Opportunity to contribute to product safety, compliance, and customer experience.
• Professional growth opportunities through exposure to advanced documentation practices and industry standards.
• Stable full-time employment opportunity.
• Supportive workplace environment focused on quality, innovation, and continuous improvement.
• Equal opportunity workplace committed to diversity and inclusion.