Mangalesh V
MedTech Regulatory and Quality Engineer
- Role
- Regulatory Affairs Specialist at 美敦力
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Mangalesh V
With over 9+ years of experience in the MedTech industry, I have gained expertise in various roles including Regulatory Affairs, Application, Installation, and End-user Support/Assistance. I have hands-on experience in preparing and regulatory submissions for technical documentation to comply with EU MDR requirements. My knowledge extends to regulations such as USFDA, EU MDR/IVDR, TGA, and Health CANADA. I have had extensive exposure and practical experience with a wide range of medical products, including Critical Care devices, Monitoring, Diagnostics, Radiology, and Imaging. Additionally, I have been involved in the calibration of medical devices.Medical Devices (Regulatory)- Orthopaedic implants, instrument and general surgery devicesMedical Devices/Equipments Handled - Patient Monitor, ECG, Oxygen concentrator, CTG/Foetal Monitor, Electrosurgery/Diathermy, ventilator, Anaesthesia work station, infusion/Syringe pump, Central Nurse station, Defibrillator, Auto CPR, X-ray (Mobile and fixed), C-Arm, O.T Tables, O.T Lights, Phototherapy, Warmer, Transport incubator, Bi-Pap and C-Pap
Experience
Regulatory Affairs Specialist
Jul 2025 — Present
Education
Winpro Automation
Industrial Automation , Instrumentation Technology/Technician
St.Anns high school ,Tindivanam
HSE, Biology, General
2009 — 2011
AIHT- Anand Institute of Higher Technology
Bachelor's Degree, Electronics and Instrumentation Engineering
2011 — 2015
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