Technical Writer II

Hybrid position - 3 days (preferably T, W, TH) onsite in AH
Job Purpose
The 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)

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

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