Asha Augustine Email & Phone Number

Hardworking and dedicated Biomedical Engineer and Regulatory affairs specialist, successful at preparing and documenting regulatory paperwork and other documentation, Tireless in maintaining current understanding of legal regulations in order to keep all products compliant, knowledgeable in home healthcare and hospital medical devices. Possess 6 years of medical devices industry experience with good knowledge on many medical devices. Highly committed and dedicated to collecting scientific data and interacting with clients and regulatory authorities.> S E G M E N T S D E A L T : Medical devices-Regulatory affairs, Premarket submissions, Impact assessment, Hazard analysis, Gap assessments, Technical documentation, technical writing , Regulatory Due diligence, Establishment registration and listing, Medical device ISO and IEC Standards, Cardiology , Patient monitoring ,Respiratory care, Advanced Respiratory diagnostics and Ventilation , Healthcare IT, Homecare devices, sleep therapy, Emergency care.> R O L E S : Regulatory affairs- Project specialist_ Due Diligence, Project Associate- Product, Product specialist, Application specialist, technical support , product support, Sales and marketing> E Q U I P M E N T E X P E R T I S E : Defibrillators & AEDs BiPAPs & CPAPs Home Sleep Test & Oxygen concentrators Patient Monitors & pulse oximeters Resting ECG & Exercise ECG Holters & Ambulatory BP Monitors Body Box plethysmography & DLCO Pulmonary function test & CPET Mechanical CPR Syringe pumps & infusion pumps Suction apparatus & DVT Geriatric & mobility care equipment

Listed skills include Medical Devices, Microsoft Office, Healthcare, Microsoft Excel, and 17 others.