Medical Device Labelling Specialist
4 days ago
We are seeking a highly skilled Medical Device Labelling Specialist to join our team at L&T Technology Services.
About the RoleThis is an exciting opportunity to work with a leading global technology services company, driving innovation and growth in the medical device industry.
The successful candidate will be responsible for labelling and documentation of medical devices, ensuring compliance with regulatory requirements such as FDA 21CFR Part 820 and ISO 13485.
Key Responsibilities- LABELLING DESIGNER - Label design and creation using Loftware, Priysm 360, Adobe InDesign, Illustrator
- REGULATORY COMPLIANCE - Update all labels, pre-printed artworks, and IFUs/Manuals with UK CA Regulation (EU MDR 2017/745)
- LABELLING TOOLS - Collect labels from Windchill PLM, labeling compliance across different sites
- CHANGE MANAGEMENT PROCESS - Initiation of labelling change management process in PLM and support for end-to-end PLM approval and process
- Bachelor's degree in Mechanical / Electrical / Electronic Engineering or MS in engineering preferred
- At least 3-5 years of experience in labelling and Loftware, Priysm 360, Adobe InDesign, Illustrator
- Good understanding of label, IFU and technical files with respect to Annexure I & II
- Familiarity with ISO 13485, ISO 15223, UDI, MDR, other applicable regulatory standards
- Knowledge of EU Medical device regulation like Medical Device Directive 93/42/EEC
The successful candidate will enjoy a competitive salary of ₹800,000 - ₹1,200,000 per annum, commensurate with experience.
In addition to a lucrative compensation package, you will have access to a range of benefits including comprehensive health insurance, retirement plan, and paid time off.
We are committed to creating a diverse and inclusive workplace that promotes professional growth and development.
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