Technical Writer IIThe Technical Writer II is 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.
Key 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.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Required Qualifications
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.
Core Competencies:
Exceptional eye for detail, critical thinking, strong cross-functional communication skills, maintenance of effective relationships with subject matter experts, and the ability to simplify dense terminology.
Preferred Qualifications:
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.
