This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Technical Writer based in the United States.
The Senior Technical Writer will play a critical role in developing clear, accurate, and compliant documentation that supports safe and effective product use.
This position focuses on creating and managing labeling materials, technical documentation, and user-facing content within a regulated environment.
You will collaborate with regulatory, engineering, quality, marketing, and clinical teams to ensure documentation meets global standards and business objectives.
The ideal candidate combines strong writing skills with technical understanding and the ability to simplify complex information for diverse audiences.
You will manage documentation workflows, review processes, and continuous improvements while contributing to product quality and compliance.
This role offers the opportunity to make a direct impact on customer experience, usability, and regulatory success.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Technical Writer based in the United States.
The Senior Technical Writer will play a critical role in developing clear, accurate, and compliant documentation that supports safe and effective product use.
This position focuses on creating and managing labeling materials, technical documentation, and user-facing content within a regulated environment.
You will collaborate with regulatory, engineering, quality, marketing, and clinical teams to ensure documentation meets global standards and business objectives.
The ideal candidate combines strong writing skills with technical understanding and the ability to simplify complex information for diverse audiences.
You will manage documentation workflows, review processes, and continuous improvements while contributing to product quality and compliance.
This role offers the opportunity to make a direct impact on customer experience, usability, and regulatory success.
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.
- Support risk management activities by reviewing documentation impacts related to safety, usability, and product performance.
- Perform quality checks to ensure documentation accuracy, completeness, and compliance.
- Manage multiple documentation projects simultaneously, tracking timelines, milestones, and deliverables.
- Identify opportunities to improve documentation processes, workflows, and efficiency.
- Support training materials and communication resources related to product operation and safety.
- Associate degree or equivalent from a two-year college or technical school, combined with four years of related experience and/or training; or an equivalent combination of education and experience.
- 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.
- 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.
- 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.
The Senior Technical Writer will be responsible for creating, maintaining, and improving technical documentation and labeling materials while ensuring compliance with applicable industry regulations and quality standards. This role requires strong attention to detail, cross-functional collaboration, and the ability to manage multiple documentation projects from development through approval.
Requirements:
The ideal candidate is an experienced technical writing professional with expertise in regulated environments, particularly medical devices or related industries. They should have excellent communication skills, strong organizational abilities, and the capacity to transform complex technical information into accessible documentation.