Sujith Mallikarjuna has over 10 years of experience in Regulatory Affairs. He has led the RA departments for diagnostics, biologics, medical device, combination products and tissue segments at multiple medical device companies. He has extensive US FDA and EU MDR experience. He also has international regulatory registration experience in Canada, APAC, EMEA, and LATAM. He has successfully supported MDSAP, EU MDR, EU MDD, and EU IVDR audits both in the front room and the back room. Mallikarjuna has extensive design control and risk management experience and New Product Introductions experience. He was also part of multiple work groups in AdvaMed and MedTech and has performed regulatory intelligence functions. He has a master’s degree in Regulatory Science from the University of Southern California and a master’s in management. He has a bachelor’s degree in pharmacy.
Mallikarjuna’s passion is to bring new medical device technologies into the market with focus on patient safety and device effectiveness. He has experience generating and executing regulatory strategies for technologies that have no precedent in the market. He has consulted with multiple startups and provided them with input into team organization, quality management system setup, and faster access to the market via innovative regulatory pathways.