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- ...Ensure adherence to FDA 21 CFR Part 820, Part 11, ISO 13485, EU MDR, and other regulatory frameworks Conduct Computer System Validation (CSV) and ensure GAMP 5 compliance Oversee regulatory submissions processes including 510(k) and PMA Perform IT audits, risk...Suggested
EPAM Systems
Coimbatore9 days ago Rs 5 - 9.5 lakhs p.a.
...Scripting ~ Ability to write Python scripts for REST API calls data extraction and transformation ~ Experience in exporting data to CSV or loading into Oracle tables ~ Data Normalization ~ Strong understanding of normalization concepts at both database and Ab Initio...SuggestedLTM
Coimbatore6 days ago- ...documentation expectations PREFERRED EXPERIENCE Experience in MedTech, Pharma, or regulated manufacturing Exposure to ISO 13485, GxP, CSV, or validation-aligned documentation Familiarity with MES, QMS, Historian, or industrial data sources Background in predictive...SuggestedHybrid work
NovintiX
Coimbatore2 days ago
