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Regulatory Engineer Cyient

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 2 weeks ago

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