Design and Implementation Engineer
2 days ago
Job Overview
As a Product Labeling Specialist, you will be responsible for creating and modifying label templates using labeling tools/systems. Your expertise in regulatory standards, including FDA 21CFR Part 820, ISO 13485, ISO 15223, UDI, MDR, and EU Medical device regulation like Medical Device Directive 93/42/EEC, is crucial to ensuring compliance.
Key Responsibilities:
- Develop and update labels, pre-printed artworks, and IFUs/Manuals according to UK CA Regulation [EU MDR 2017/745].
- Initiate the Labeling Change Management Process in PLM and support end-to-end PLM approval and process.
- Collaborate with cross-functional teams to ensure seamless implementation of labeling strategies.
Requirements:
- Bachelor's degree in Mechanical/Electrical/Electronic Engineering or Master's degree in Engineering preferred.
- Minimum 3-5 years of experience in a similar field.
A dynamic work environment with opportunities for growth and development.
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