🧬 Clinisys – Senior Regulatory Analyst
🏢 Company: Clinisys
💼 Post: Senior Regulatory Analyst
📍 Location: Bangalore
📅 Last Date: 30 September 2026
🏥 Industry: Pharma / Healthcare / Life Sciences
💼 Experience: 5–8 Years
🎓 Qualification: Bachelor’s Degree in Regulatory Affairs / Science / Engineering / Life Sciences / Healthcare / IT / Business or related field
⭐ Master’s degree & RAC certification preferred.
🔹 Key Responsibilities:
• Regulatory submissions & product registrations
• FDA / EU MDR / IVDR / UK MDR / MHRA compliance
• Regulatory impact assessment for software & product changes
• Technical documentation & regulatory records
• Regulatory intelligence & compliance monitoring
• Support audits, inspections & regulatory authority queries
• Product lifecycle & post-market compliance
• Support CAPA, risk management & surveillance activities
🧪 Preferred Experience:
• Medical Devices / Diagnostics
• Healthcare & Laboratory Software
• Software as Medical Device (SaMD)
• LIMS / LIS
• Global Regulatory Affairs
⭐ Key Skills: FDA | EU MDR | IVDR | ISO 13485 | ISO 14971 | IEC 62304 | Regulatory Intelligence | LIMS/LIS | AI-enabled tools
🚀 Apply Online: https://careers.clinisys.com/jobs/8269786-senior-regulatory-analyst
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