Monali Bhansali Shah
Head of Department @Syrma Johari Medtech Limited
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WORK HISTORY
Head of Department @Syrma Johari Medtech Limited
Pune, IN
Strategy, Business Growth and Marketing
EDUCATION
Drexel University College of Engineering
Master of Science - MS, Biomedical/Medical Engineering
Indian Institute of Management, Kozhikode
Advanced Strategy Management for CXOs, Business and Corporate Strategy
Drexel University
Master of Science - MS, Bioengineering and Biomedical Engineering
Harvard Business School Online
Design Thinking and Innovation
SKILLS
ABOUT MONALI BHANSALI SHAH
As a visionary with over 16 years of experience in the medical device industry, I am dedicated to driving strategic growth and innovation in the MedTech sector. Currently, I serve as the Head of Strategy, Business Growth, and Marketing at Syrma Johari Medtech Ltd, where I leverage my deep expertise to shape the future of healthcare technology. My strategic initiatives have consistently bridged the gap between cutting-edge technology and market needs, ensuring our services excel in performance, patient safety, and regulatory compliance.My journey in the MedTech industry has been marked by significant contributions across design, engineering, manufacturing, and Quality Assurance & Regulatory Affairs (QARA).With strong domain expertise in biomedical engineering, I effectively guide product development from concept to market. My mission is to help clients navigate the complex and dynamic landscape of the MedTech industry, achieve compliance, and optimize their products and processes. I have a proven track record of managing and executing system requirements, DHF remediation, global submissions, strategy and pathway planning, clinical evaluation, post-market surveillance, risk management, and manufacturing process understanding for various medical devices and IVDs, including orthopedics, surgical instruments, point of care devices, respiratory, interventional cardiology & urology, home care, diabetes, and patient care technologies.I possess extensive knowledge and experience in regulations with respect to EU MDR compliance, FDA, CDSCO, ANVISA, Health Canada, and CFDA. My passion lies in enhancing the quality and safety of healthcare products and services by empowering innovation and growth in the healthcare and life sciences sector.I am immensely passionate about enhancing the quality and safety of healthcare products and services by empowering innovation and growth in the healthcare and life sciences sector.
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