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Karwell Technologies | Minneapolis, Minnesota, United States | Posted May 05, 2026
Position Overview
Job Description:
- We are seeking a highly skilled Medical Device Labeling Engineer with strong expertise in regulatory compliance, labeling development, and cross-functional coordination. This role also involves onsite leadership and customer engagement, serving as a key liaison between client teams and offshore labeling groups.
- The ideal candidate will bring deep knowledge of US & EU labeling regulations, strong project management capabilities, and experience working in a fast-paced, multi-stakeholder environment.
Responsibilities:
- Labelling Engineering & Compliance:
- Develop, review, and maintain labeling content including IFUs, packaging labels, inserts, and e-labeling.
- Ensure compliance with global regulations and standards:
- FDA (21 CFR Part 801 & 820)
- EU...