Technical Writer II

TALENT Software Services; Saint Paul (MN); On-site; USD 65,000 - 90,000; Full time

Job summary

TALENT Software Services is seeking a Technical Writer II in Minnesota to develop and maintain high-quality Instructions for Use (IFUs) and product labels for clinician use, patient safety, and regulatory compliance.

The ideal candidate will translate complex technical information into clear, user-focused content, collaborating with engineering, quality, regulatory, and other teams to ensure accuracy and regulatory alignment.

Qualifications

• Bachelor’s degree in Technical Communication, English, Biomedical Engineering, or Life Sciences.
• 2+ years technical writing in regulated medical/manufacturing environments.
• Proficiency with MS Office, Adobe Creative Suite, and content/quality management systems.

Responsibilities

• Write and update clinician IFUs, patient manuals, and product labels.
• Lead reviews with engineering, quality, regulatory, clinical, marketing, and manufacturing.
• Ensure materials comply with FDA, ISO, and EU MDR standards.
• Maintain revision histories and risk-management documentation.
• Plan and manage multiple documentation projects concurrently.
• Build quality into all work processes.

Skills

Technical writing

Regulatory compliance

Cross-functional collaboration

Document control

Project management

Attention to detail

Education

Bachelor's degree in Technical Communication/English/Biomedical Engineering/Life Sciences

Tools

MS Office

Adobe Creative Suite

Content Management Systems

Quality Management Systems

Job description

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.

Description:

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.

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