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...
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