Chair, Regulatory Affairs Southeast Asia Center of Excellence, APACMed
Director, Regulatory Affairs, Johnson & Johnson MedTech
Sharad Mi. Shukla, RAC is currently heading the regulatory affairs (Medical Devices) for South East Asia at Johnson & Johnson Medical. Sharad has over seventeen years of experience in MedTech industry with hands-on in Design & Development, Manufacturing, Clinical, Quality & Regulatory Affairs.
Prior to Johnson & Johnson, Sharad worked with GE Healthcare as Global Regulatory Affairs Leader and was responsible for leading multiple strategic regulatory projects including NPI’s for anesthesia, respiratory & maternal infant care devices. In his previous experience he worked with European certification/ notified body as ISO 13485 & CE Marking lead auditor for medical device. He worked with different start-ups as well and has been instrumental in establishing Quality & regulatory functions & services from the scratch and devising regualtory strategies for global markets. With his strong passion for training and capacity building for quality & regulatory professionals, he is actively engaged with regulatory shaping and advocacy with different industry forums. Recently, he is elected as Chair of Capacity Building Workgrop for the APACMed RA Committee.
Sharad has a MS in Microbiology. He also earned Regulatory Affairs Credentials (RAC) for US & EU from RAPS, USA and actively engaged with RAPS as technical expert & author. He has also moderated multiple RAC study groups for regualtory professionals.