Technical Labeling Specialist

$45-50/hr

Onsite/Hybrid in Minneapolis metro

Full-time

Job Description

We are looking for a skilled Technical Communications Specialist to create, revise, and maintain labeling and technical documents, including user manuals, quick-start guides, and labels. This role involves developing Instructions for Use (IFUs) from the ground up, gathering information from various departments, and ensuring all labeling meets applicable regulations and industry standards. You will coordinate the translation of technical documents into multiple languages and collaborate across teams to ensure accuracy and compliance.

Work Environment

The role requires on-site presence for 5 days during the first 1-2 months for training and team integration. Afterwards, it will transition to 2-3 days on-site with flexible scheduling options. The role allows for starting work from home in the morning and attending afternoon meetings in the office. Remote work is possible during adverse weather conditions.

Responsibilities

• Create, revise, and maintain labeling and technical documents such as user manuals, quick-start guides, and labels.
• Develop Instructions for Use (IFUs) from the ground up by gathering necessary information from different departments.
• Ensure all labeling complies with applicable regulations, industry standards, and company quality policies.
• Coordinate and manage the translation of technical documents into multiple languages, ensuring accuracy and compliance with global regulations.
• Collaborate with engineering, regulatory, quality, and product development teams to extract necessary information for documentation.
• Use tools like Adobe InDesign to produce professional-quality documents, layouts, and graphics.
• Provide clear and efficient writing throughout all documentation.
• Consistently pay attention to detail, with strong copyediting and proofreading skills to ensure accuracy, consistency, and clarity.
• Provide estimates of deliverable development time, manage timelines, and track projects until completion.
• Manage multiple documentation projects simultaneously, meeting deadlines and delivering high-quality work.
• Demonstrate motivation and organization, managing time effectively in a fast-paced environment.

Essential Skills

• 3-5 years of experience in technical writing or technical communications within the medical device industry.
• Proficiency in Adobe InDesign and Microsoft Office Suite.
• Experience with FDA Regulation and EUMDR.
• Excellent written and verbal communication skills.
• Strong attention to detail and accuracy in documentation.
• Ability to independently gather information and work effectively in a cross-functional team environment.

Additional Skills & Qualifications

• Experience with Adobe Illustrator, Adobe Photoshop, and document management systems is a plus.
• Knowledge of regulatory affairs and medical device labeling.
• Graphic design and editing skills.