Technical Writer II

Integrated Resources, Inc ( IRI ); Saint Paul (MN); Hybrid; USD 65,000 - 85,000; Full time

Job summary

Integrated Resources, Inc. is seeking a Technical Writer II for a hybrid position with onsite work an AH location.

The candidate will develop, edit, and maintain Instructions for Use (IFUs) and labels to support clinician use, patient safety, and regulatory compliance. The ideal candidate will translate complex technical information into clear user-focused content, work with engineering, quality, clinical, regulatory, marketing, and manufacturing teams, and ensure strict adherence to FDA, ISO,

Qualifications

• Must have strong writing and editing skills.
• Experience with regulatory documents and labeling is required.
• Excellent collaboration with diverse teams is essential.

Responsibilities

• Write and edit IFUs, patient manuals, and product labels.
• Lead document reviews with engineering, quality, regulatory, marketing, and manufacturing teams.
• Ensure materials comply with FDA, ISO, and EU MDR guidelines.
• Maintain revision histories and documentation for risk management.
• Develop and manage project plans for documentation deliverables.

Skills

Attention to detail

Cross-functional collaboration

Regulatory compliance

Critical thinking

Education

Bachelor's degree in Technical Communication, English, Biomedical Engineering, or Life Science

Tools

Microsoft Office Suite

Adobe Creative Suite

Content Management Systems

Job description

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