Medical Device Labeling Specialist

Actalent; Minnesota; On-site; USD 65,000 - 90,000; Full time

Job summary

Actalent seeks a Labeling Specialist to develop and manage medical device labeling using BarTender in a regulated environment. You will own the label lifecycle, author labeling content, and collaborate with packaging, regulatory, QA, and document control to ensure regulatory and packaging compliance.

Ideal candidates bring 4+ years in medical device labeling, strong technical writing skills, and hands-on BarTender experience, with attention to detail and a collaborative mindset for a fast-paced

Qualifications

• 4+ years in medical device labeling or related roles.
• Experience with BarTender labeling software in a regulated setting.
• Knowledge of ISO 13485 and 21 CFR 820 requirements.
• Experience with labeling content authoring and documentation.

Responsibilities

• Design, develop, and maintain medical device labels using BarTender in line with regulatory quality requirements.
• Manage full label lifecycle from creation to retirement of labeling content.
• Author and update labeling content and related technical documentation.
• Collaborate with packaging engineering, regulatory, QA, and document control to ensure label compliance.
• Support new and existing labels with integration to packaging design and manufacturing.
• Ensure activities comply with medical device quality system standards (ISO 13485, 21 CFR 820).
• Use PLM and QMS to route, track, and control labeling documents and approvals.
• Troubleshoot labeling issues and coordinate timely resolution with stakeholders.
• Own labeling projects and work independently with high accuracy.
• Ask questions and seek clarification to maintain progress and quality.
• Contribute to continuous improvement of labeling processes and templates.
• Support audits and inspections with labeling documentation.

Skills

BarTender

Medical labeling

Regulatory knowledge

Technical writing

Attention to detail

Independent work

Cross-functional collab

Clarifying questions

Documentation

Tools

Agile PLM

Windchill

PLM/QMS platforms

Job description

Actalent seeks a Labeling Specialist to develop and manage medical device labeling using BarTender in a regulated environment. You will own the label lifecycle, author labeling content, and collaborate with packaging, regulatory, QA, and document control to ensure regulatory and packaging compliance.

Ideal candidates bring 4+ years in medical device labeling, strong technical writing skills, and hands-on BarTender experience, with attention to detail and a collaborative mindset for a fast-paced