R&D Technical Writing Analyst

GForce Life Sciences; Salt Lake City (UT); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Job summary

GForce Life Sciences seeks a detail-oriented Business Professional - Analyst, R&D Technical Writing, to develop and review labeling documentation for medical devices. You will ensure materials meet GMP and QSR standards and align with regulatory expectations to support patient safety and customer satisfaction.

This role emphasizes independent work, collaboration with R&D, Legal, Regulatory, and Quality, and effective communication across cross-functional teams to maintain accurate, compliant

Qualifications

• Bachelor’s degree or equivalent practical experience.
• Understanding of GMP and QSR labeling standards.
• Proficiency with GLS/Prisym, Adobe CS, and MS Office.
• Experience with Zebra printers and barcode tools.
• Ability to work in cross-functional teams with accuracy.

Responsibilities

• Develop, review, and maintain labeling documentation per regulatory standards.
• Design labeling layouts using GLS/ Prisym and Adobe CS.
• Collaborate with R&D, Regulatory, Legal, and other teams.
• Verify printed labels and troubleshoot printer issues.
• Maintain records in PLM and other data systems.
• Update SOPs and technical docs with graphics.

Skills

Attention to detail

Cross-functional collaboration

Technical writing

Regulatory knowledge

Communication skills

Education

Bachelor's degree

Tools

GLS/Prisym

Adobe Creative Suite

Microsoft Office

Zebra printers

Barcode verification tools

Job description

We are seeking a detail-oriented and collaborative Business Professional - Analyst, R&D Technical Writing, to join our dynamic team. This individual contributor role plays a pivotal part in developing, maintaining, and reviewing labeling documentation that supports our innovative medical devices. The ideal candidate will ensure all labeling materials are accurate, compliant with GMP and QSR standards, and aligned with company and regulatory expectations. This position offers an excellent opportunity for a proactive professional to work independently, leverage technical expertise, and contribute to projects that impact patient safety and customer satisfaction.

Key Responsibilities

• Assist in the timely development, review, and maintenance of labeling documentation, including drawings, change orders, and specifications. Ensure all materials meet strict quality standards and regulatory compliance (GMP, QSR).
• Design labeling layouts and graphics using standard templates, style guides, and labeling software tools such as GLS/Prisym, Adobe Creative Suite, and Microsoft Office.
• Support the setup and configuration of new labels or label changes using the Stryker Neurovascular labeling system, including onsite label printing (e.g., Zebra printers) and barcode verification tools.
• Troubleshoot and resolve printer or equipment issues related to label printing and verify the quality and accuracy of printed labels.
• Collaborate with cross-functional teams—R&D, Packaging Engineers, Legal, Regulatory Affairs, Product Marketing, Design Assurance, Quality, Manufacturing, and Operations—to ensure labeling aligns with product specifications, data backing, and compliance requirements.
• Participate actively in project team meetings, monitor project progress, and coordinate task execution to meet deliverables efficiently.
• Support review and revision of technical documentation such as Standard Operating Procedures (SOPs), Work Instructions, engineering documents, and other technical literature, ensuring clarity, consistency, and appropriateness for the target audience.
• Maintain accurate records of labeling and technical documentation within site-specific data management systems (e.g., PLM).
• Contribute to problem-solving initiatives related to labeling issues, documenting resolutions within the quality system.
• Assist in updating departmental and quality system documentation, including SOPs and templates, with graphical content and relevant technical information.
• Ensure compliance with all quality policies and support process improvements for streamlined documentation and approval workflows.
• Work cooperatively with stakeholders to facilitate labeling review, approval, and implementation processes.

Qualifications:

• Bachelor’s degree in a relevant field or equivalent practical experience.
• Demonstrated understanding of labeling systems, technical document development, and regulatory standards (GMP, QSR).
• Proficiency with labeling design tools, including GLS/Prisym, Adobe Creative Suite, and Microsoft Office suite.
• Experience with label printing hardware and troubleshooting (e.g., Zebra printers, barcode verification tools).
• Strong attention to detail and ability to scrutinize technical documents and labeling for accuracy.
• Excellent communication and collaboration skills, with a proven ability to work independently and in cross-functional teams.
• Familiarity with document control systems such as PLM or similar data management tools.
• Ability to apply professional judgment, practices, and prior experience to solve technical issues and ensure compliance.