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.

📌 Technical Writer (Maharashtra)
🏢 Capgemini Engineering
📍 Maharashtra