Prepare & manage regulatory submissions for CDSCO, US FDA (510(k)) EU& MDR
Device Master Files (DMF)Technical Documentation
Clinical Evaluation Reports (CER)
Risk Management Files
Software documentation aligned with IEC 62304
EU MDR 2017/745
Required Candidate profile
4–8 yrs of Exp in Medical Device Regulatory Affairs &CDSCO;
Proven Exp with regulatory submissions for medical devices / (SaMD).
Cardiac monitoring devices
Holter ECG systems
Diagnostic medical devices
📌 Senior Associate Regulatory Affairs Medical Devices (Chennai)
🏢 Trion consultancy Services
📍 Chennai
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