Technical Writer II

Technical Writer II

Education: Bachelor's degree in Technical Communication, English, Biomedical Engineering, or a Life Science discipline.

Experience: Minimum of 2+ years of technical writing experience within a regulated, medical, or manufacturing environment.

Technical Proficiency: Mastery of tools like Microsoft Office Suite, Adobe Creative Suite, and experience using Content Management and Quality Management Systems.

Advanced degree in technical communications, English or similar.

Document creation using an XML-based content management system.

Writing for multiple audiences (clinicians and patients).

Strong attention to detail.

Knowledge of medical terminology and anatomy.

Proven understanding of literature and labeling development in a heavily-regulated environment.

Use of critical-thinking and problem-solving skills to identify risk and develop creative solutions.

Insight Global is looking for a Technical Writer II to join a leading medical device manufacturing company to be responsible for developing, editing, and maintaining high-quality Instructions for Use (IFUs) and labels that support clinician use, patient safety, and regulatory compliance. The ideal candidate is detail-oriented, collaborative, and skilled at translating complex technical information into clear, user-focused content.

Responsibilities:

• Writing: Exceptional writing and communication skills.
• Document Authoring: Create and update clinician IFUs, patient manuals, and product labels.
• Cross-Functional Collaboration: Lead documentation reviews with engineering, quality, clinical, regulatory, marketing, and manufacturing teams to ensure technical accuracy and regulatory compliance.
• Regulatory Compliance: Ensure all materials conform to strict standards including FDA guidelines, ISO norms, and EU MDR requirements.
• Document Control: Create and maintain precise revision histories and supporting documentation for risk management.
• Project Management: Create and adhere to project plans for document completion. Manage multiple projects simultaneously as required.