Live opening · Posted 3 days ago
Technical Writer
Capgemini Engineering · Pune District, Maharashtra, India (On-site)
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At a glance
The key details from the original listing.
CompanyCapgemini Engineering
LocationPune District, Maharashtra, India (On-site)
Work modeNo
Source
Linkedin
ListedPosted 3 days ago
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About the role
Description supplied by the original job listing.
Experience- 2 to 4 Yrs
Location- Pune
Notice Period- 0-30 days
Mandatory :
• EU MDR 2017/745, FDA 21 CFR Part 820, ISO 13485, ISO 14971.
• FDA 510(k), eSTAR Submission, CE Marking, Global Regulatory Registrations
• Technical Writing, SRS, SDD, Device Manuals, IFU/eIFU, Regulatory Documentation, Design Traceability.
• Risk Management, GSPR, NB Coordination, Technical File Compilation
• SaMD, IEC 62304, IEC 62366, Medical Device Software Documentation.
Key Responsibilities
• Prepare and maintain Technical Documentation, GSPR, Risk Management Files, Device Master Records, and regulatory dossiers for EU MDR compliance.
• Author and review technical documents including Software Requirements Specifications (SRS), Software Design Descriptions (SDD), Device Manuals, IFU, eIFU, Technical Files, Design Documentation, and Regulatory Reports
• Support FDA 510(k), eSTAR, CE Marking, and global product registration activities.
• Perform risk management activities, Design FMEA, User FMEA, and design traceability.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory teams throughout the product lifecycle.
Work arrangement
No
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