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5.0 - 15.0 years
0 Lacs
pune, maharashtra, india
On-site
Tata Elxsi is truly your home to a billion possibilities. We believe in opportunities for everyone to be bold and curious and seek to shape the future. Explore what's possible, discover what you love to do, and find accelerated paths for growth. At Tata Elxsi, you matter. Role- Labelling Specialist Job Description: The Label Designer for re-designing medical device labels as per brand standard guidelines for regulatory compliance. Label designer should be well-versed in Loftware Spectrum 4.6 version or 4.2 version. Provide creative solutions in medical device labelling and packaging design and validation. Title: Label Specialist Experience: 5 - 15 years Domain: Medical Device Location: Pune ...
Posted 3 days ago
7.0 - 12.0 years
0 Lacs
bengaluru, karnataka, india
On-site
Job Description Summary The right candidate will be placed in the Product engineering or product development team. Role and responsibilities will include leadership and technical support to a cross-functional team (across geography and domain). This involves leading the independent project, technical discussions, decision making, driving projects in coordination with different sites, rigor in planning & execution steps, monitoring, and control. The Lead Engineer will have to inclusively lead TCI team members and ramp up capabilities within the team. This will need hands-on execution of the project, supporting other team members, and establishing good practices for cross-platform project exec...
Posted 1 month ago
3.0 - 5.0 years
0 Lacs
bengaluru, karnataka, india
On-site
Responsibilities Lead preparation of Compliance Data Reports (CDRs) and Test Report Forms (TRFs) to demonstrate compliance with IEC 62304, IEC 82304-1, IEC 62366-1, ISO 15223-1, ISO 20417, eIFU Regulation (EU-2021/2226), EU MDR [2017/745], UKCA, Canadian (SOR/98-282), and Australian (TGR) medical device regulations.? Analyze historical Request for Change (RfS) and design change data to develop and maintain regulatory compliance checklists and criteria for software medical device documentation.? Perform systematic gap assessments on change records and documentation to identify compliance risks, deficiencies, and areas for improvement per current regional and international requirements.? Devel...
Posted 1 month ago
7.0 - 12.0 years
0 Lacs
bengaluru, karnataka, india
On-site
Job Description Summary The right candidate will be placed in the Product engineering or product development team. Role and responsibilities will include leadership and technical support to a cross-functional team (across geography and domain). This involves leading the independent project, technical discussions, decision making, driving projects in coordination with different sites, rigor in planning & execution steps, monitoring, and control. The Lead Engineer will have to inclusively lead TCI team members and ramp up capabilities within the team. This will need hands-on execution of the project, supporting other team members, and establishing good practices for cross-platform project exec...
Posted 1 month ago
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