Akhilesh Kumar Sharma
Senior Engineer @Tata Elxsi
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WORK HISTORY
Senior Engineer @Tata Elxsi
Pune, IN
1- Experienced in preparing documentation and reviewing technical files as per US-FDA & EU-MDR regulatory requirements to get 510(k) & CE marking approval. 2—Creation and technical review of Risk management documents, including the Risk management plan, Risk analysis worksheet, Design FMEA, Application FMEA, and Risk management report.3- Design documents include the Design development plan, Input Output Verification Validation Table (Design Traceability Matrix), Usability engineering file, and Design verification and validation protocols/reports.4-Regulatory documents including technical file and GSPR, IFUs and label redlining.
EDUCATION
Dr. A.P.J. Abdul Kalam Technical University
Bachelor of Technology - BTech
National Institute of Technology, Kurukshetra, Haryana
Master of Technology - MTech
ABOUT AKHILESH KUMAR SHARMA
I have managed complex regulatory submissions for global markets including the US FDA (510(k), PMA), EU MDR (Technical Files, GSPR), CDSCO. I have been instrumental in preparing labeling content per ISO 15223-1 and 21 CFR Part 801 requirements, as well as managing UDI data for both GUDID and EUDAMED databases. My experience also includes DHF remediation, risk management documentation (dFMEA, AFMEA), and product lifecycle support aligned with ISO 13485, ISO 14971, and IEC 62304. Additionally, my engineering mindset and hands-on technical skills—from microcontroller-based prototypes to Power BI dashboards—allow me to bridge technical and regulatory teams effectively. I take pride in my proactive attitude, award-winning contributions, and continuous learning approach, including certifications in AI and app development.
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