Hybrid Technical Writer II — Medical Devices & IFUs

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

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,