
Regulatory Labeling Specialist
1 day ago
Job Title: Regulatory Labeling Specialist
About the Role:
We are seeking an experienced Regulatory Labeling Specialist to join our team. The ideal candidate will have a strong background in labeling design and development, with a focus on regulatory compliance.
Key Responsibilities:
- Design and develop label templates that meet regulatory standards such as FDA 21CFR Part 820, ISO 13485, ISO 15223, UDI, MDR, and EU Medical Device Directive 93/42/EEC.
- Update labels, pre-printed artworks, and IFUs/manuals to reflect the latest regulatory requirements.
- Manage the labeling change process within our Product Lifecycle Management (PLM) system.
- Utilize various tools such as Adobe Indesign, Illustrator, Priysm, Nicelabel, Codesoft Loftware, and Windchill for labeling design and creation.
Requirements:
- Bachelor's degree in Mechanical, Electrical, or Electronic Engineering or Master's degree in engineering preferred.
What We Offer:
A dynamic work environment with opportunities for growth and professional development.
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