Labeling Specialist, Medical Device & PLM
Overview
You will own labeling specifications, packaging artwork, and documentation for medical products across the global portfolio, ensuring compliance and accuracy for product launches. Your work directly impacts patient safety and regulatory approvals. You will collaborate with Regulatory Affairs, Quality, Marketing, and Engineering teams to drive labeling changes from concept to release. This role blends hands-on artwork development in Adobe Illustrator with document control in PLM systems like Enovia and Windchill. You will shape labeling processes and systems, influencing efficiency and compliance across the organization.
What You'll Do10
- 1Create, review, and maintain labeling specifications and packaging artwork for medical products using Adobe Illustrator.
- 2Manage labeling changes through the full product lifecycle, from initial design to implementation and release.
- 3Release and maintain specifications and drawings within PLM systems such as Enovia and Windchill.
- 4Partner with Regulatory Affairs, Quality, and Engineering teams to support labeling projects and product changes.
- 5Review labeling content for accuracy, consistency, traceability, and compliance with U.S. and international regulations.
- 6Support global product launches by coordinating labeling updates and documentation changes.
- 7Monitor labeling regulations and industry requirements, incorporating updates into labeling processes.
- 8Identify and implement improvements to labeling workflows, systems, and quality processes.
- 9Manage multiple labeling projects simultaneously, meeting deadlines and compliance requirements.
- 10Communicate project status, risks, and issues to internal stakeholders.
Requirements10
- 12+ years of experience in labeling, regulatory, quality, documentation control, packaging, or a related function.
- 2Bachelor's degree in a related field.
- 3Experience creating, reviewing, or managing medical product labeling and packaging documentation.
- 4Experience working with PLM systems such as Enovia, Windchill, or similar document management platforms.
- 5Proficiency with Adobe Illustrator.
- 6Strong attention to detail and document review skills.
- 7Ability to manage multiple projects and priorities independently.
- 8Strong written and verbal communication skills.
- 9Experience working within a regulated industry environment.
- 10Preferred: experience in medical device, pharmaceutical, biotech, or other highly regulated industries.
Salary Insight
$62 - $79k per year
Location
Required Skills
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