Senior Director, Regulatory Affairs, Government Affairs and Quality, APAC , Stryker
GA Vice-Chair, APACMed GAMA Committee
Mr. Shivkumar Hurdale holds the position of Senior Director - Regulatory Affairs, Government Affairs and Quality - APAC. In this role, he provides regulatory strategic leadership support across Asia Pacific (APAC) region in Stryker.
Shivkumar is a certified ISO 13485:2016 Lead Auditor and has completed Global Internationally Certified course in EU Medical Device Regulation (2017/745) and MEDDEV 2.7/1 rev.4 by Oriel STAT A MATRIX, New Jersey, USA. Shiv has also successfully completed PG Diploma in Leadership Management form Thomas International, USA and CDS Institute, Bangalore.
Shiv has worked with Johnson & Johnson, Medtronic, Abbott, and Novartis Healthcare. He has more than 19 years of experience in Manufacturing, Quality, Standards & Regulatory in single use, In-vitro, combinational Medical devices, and Pharma products in India, ASPAC and USA region.
Shiv has successfully held workshops for the training of the Standard authorities, regulators and regulatory authorities at center and state level in India and Sri Lanka. Shiv also represents Govt of India (BIS) in ISO TC/150 Committee.
Mr. Hurdale holds a Post Graduate degree in Pharmaceutical technology from Vinayaka Missions Research Foundation, Hyderabad.
Mr. Shivkumar is currently Vice Chair of Govt Affair Committee and Vice-Chair of Regulatory Intelligence Committee of APACMed (Asia Pacific Medical Technology Association, Singapore)
Mr. Shivkumar has Chaired and Co-Chaired Regulatory and Advocacy Sub-committees of Medical Devices in CII, FICCI, MTaI