Logo of Huzzle

Home

Matches

Explore

Manage

Labeling Specialist (Medical Device)

image

Actalent

Sep 23

Applications are closed

  • Job
    Full-time
    Mid & Senior Level
  • Consulting
    Product
  • Minneapolis

Requirements

  • 3-5 Years of Medical Device Labeling
  • Technical Writing Experience
  • FDA Regulation Experience
  • EUMDR Experience
  • InDesign
  • Illustrator
  • Excel
  • Word
  • Attention to Detail
  • Project Management
  • Motivation
  • Organization

Responsibilities

  • Develop and Manage Labeling: Create, revise, and maintain labeling, including user manuals, quick-start guides, labels, and other technical documents.
  • Regulatory Compliance: Ensure all labeling meets applicable regulations, industry standards, and company quality policies.
  • Translation Management: Coordinate and manage the translation of technical documents into multiple languages, ensuring accuracy and compliance with global regulations.
  • Collaborate Across Teams: Engage with engineering, regulatory, quality, and product development teams to extract the necessary information for documentation. The candidate must be proactive in seeking out information and initiating and managing cross-functional review cycles, especially for new IFUs.
  • Content Creation: Use tools like Adobe InDesign to produce professional-quality documents, layouts, and graphics. Provide clear and efficient writing throughout all documentation.
  • Attention to Detail: Consistently pay attention to detail, with strong copyediting and proofreading skills to ensure accuracy, consistency, and clarity.
  • Project Management: Provide estimates of deliverable development time, manage timelines and track the project until completion. Manage multiple documentation projects simultaneously, meeting deadlines and delivering high-quality work.
  • Motivation and Organization: Highly motivated and organized, capable of managing your time effectively in a fast-paced environment.

FAQs

What is the primary role of a Labeling Specialist?

The primary role of a Labeling Specialist is to develop, manage, and maintain product labeling, including user manuals, quick-start guides, and technical documents, while ensuring compliance with applicable regulations and industry standards.

What kind of experience is required for this position?

Candidates are expected to have 3-5 years of experience in medical device labeling, along with technical writing experience and familiarity with FDA regulations and the EU Medical Device Regulation (EUMDR).

What tools will I need to be proficient in?

Proficiency in tools such as Adobe InDesign, Illustrator, Excel, and Word is required for this position.

Is attention to detail important for this role?

Yes, attention to detail is crucial, as the role involves strong copyediting and proofreading skills to ensure accuracy, consistency, and clarity in all documentation.

Will I be collaborating with other teams?

Yes, the position requires collaboration across various teams, including engineering, regulatory, quality, and product development, to gather necessary information for documentation.

How is project management involved in this role?

The Labeling Specialist will manage multiple documentation projects simultaneously, providing estimates of development time, tracking project timelines, and ensuring deadlines are met with high-quality work.

How does Actalent approach diversity and inclusion?

Actalent emphasizes diversity, equity, and inclusion by hiring diverse talent, maintaining an inclusive environment, building a culture of care and recognition, and ensuring growth opportunities for all employees.

Where is this position located?

This is a hybrid position requiring some days on-site in Minneapolis, Minnesota, and some days working remotely.

What should I do if I need an accommodation during the application process?

If you need a reasonable accommodation, such as modifications in the application or interview process due to a disability, you can email actalentaccommodation@actalentservices.com for assistance.

image

Actalent

An Engineering and Sciences Services Company | People to Possible

Human Resources
Industry
5001-10,000
Employees

Mission & Purpose

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference. Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

Get notified when Actalent posts a new role

Get Hired with Huzzle

Discover jobs with AI-powered precision. Autofill and track applications, create tailored resumes, and find the best opportunities across the web – all by simply chatting.

Already have an account?