Overview In this role you will lead regulatory labeling activities to support global submissions and ensure compliant product labeling. You will author and review content for manuals, inserts, and on-product labeling, while aligning with global requirements. You'll collaborate cross-functionally to integrate labeling with design, engineering, and manufacturing. This is a chance to shape label quality in a fast-paced medtech environment that improves patient outcomes.
Responsibilities- Lead regulatory labeling activities for global submissions and variations
- Author and review content for User Manuals, product inserts, and on-product labeling
- Provide SME input on global labeling requirements and standards
- Apply branding and style guidelines to labeling
- Verify labeling compliance with applicable regulations
- Manage external providers for label artwork using Illustrator and Bartender
- Create and revise label items in the document control system
- Contribute to labeling process improvement initiatives
- Represent labeling in project teams and assess impact of design changes on labeling content
Key requirements- Bachelor's degree in scientific or engineering field
- 5+ years in medical device regulatory affairs
- Knowledge of 21 CFR
- Experience with 510(k) submission process
- Experience with EU MDR and MDD (93/42/EEC / 2007/47/EC)
- ISO 13485 knowledge
- Cross-functional collaboration with engineering, marketing, manufacturing, and legal
- Excellent written communication of technical information
- Proficiency in Microsoft Office
- Precise, thorough, and analytical; proactive in fast-paced environments
- Excellent written communication
- Proactive and adaptable
- Cross-functional collaboration
- Adobe Illustrator
- Bartender labeling software
- Labeling software
