Jagadeesha

About Jagadeesha

30+ years of Industry experience. Expert in Implementing Regulatory standards…

Experience

1. Principal Regulatory Affairs Src Ra Patient Interface Philips Innovation Campus, Bangalore

   Philips

   Jul 2016 — Present · Bengaluru, IN

   Overall 30+ Years of Industry Experience.Philips : 9+ YearsProgram Manager Q&R :20••••23 : Worked Research India as Q&R Leader - taken the Responsibility of Quality Assurance, Risk Management Officer, Regulatory Affairs, Data Privacy Officer and Clinical Study Monitor for the products and solutions developed by Research India.Program Manager Q&R:20••••25 (Aug): Regulatory Affairs Support activities for MR - HTS group.• Providing regulatory requirements on geography specific regulations and guidance, standards, software process frameworks, security and data privacy assurance and support digital health products. Supporting / reviewing Clinical studies from Regulatory point of view for MR products and Systems.Principal Regulatory Affairs Specialist:2025 (Sept)- Till date: Regulatory Affairs Support to Sleep and Respiratory Care Business.Performing submission of registration deliverables for markets, Regulatory discussions between markets and project team members, As Regulatory Lead - Involving discussions with Notified body supporting team for Global product Launch.

Education

• Basaveshwar Engineering College, Bagalkot, Karnatak University, Karnataka, India

  BE, Electronics and Communication

  1990 — 1994

Skills

• Iso 14971
• Regulatory Affairs
• Team Management
• Requirements Analysis
• Software Project Management
• Quality Assurance
• Quality Management
• Medical Device Regulation
• Visio
• Medical Device Regulatory
• Medical Devices
• Six Sigma
• Quality System
• Iso 13485
• Program Management
• Product Development
• Testing
• Management