Shikha Malik

Senior Regulatory Affairs Specialist at Medtronic

Speaker

Shikha Malik, MPharm, MS, RAC-Devices, is a senior regulatory affairs specialist at Medtronic Inc. She has eight years of medical device industry experience, with extensive experience in providing regulatory strategies for different risk classes of medical devices from early-stage product development to market submission and approval. She specializes in the US and EU (MDD and MDR) submissions along with providing regulatory support to different regions as needed for the successful launch of the product. She has also partnered with RAPS on publishing articles and writing chapters in Postmarket Requirements for Medical Devices: A Practical Guide and Global Pediatric Development of Drugs, Biologics, and Medical Devices. She was also selected by RAPS to participate in its Regulatory Compliance Exam Questions Writing opportunity. She has a master of pharmacy degree in pharmacology from India and a master of science degree in regulatory affairs from Northeastern University, Boston.