amit relia
nc jindal public school
About
Director, Regulatory Affairs at Intuitive Surgical
united states
palo alto
biotechnology
iso 13485, design of experiments, cross functional team leadership, fmea, minitab, fda, regulatory affairs, 21 cfr part 11, quality auditing, iso 14971, six sigma, spc, quality control, validation, product development, medical devices, gmp, supplier quality, biomedical engineering, design control, lean manufacturing, r&d, v&v, capa, dmaic, root cause analysis, quality system, quality assurance, continuous improvement, process simulation, auditing, iso, quality management, change control, sop, iso 9000, ce marking, computer system validation, manufacturing engineering, medical device directive, research and development, verification and validation, u.s. food and drug administration, corrective and preventive action, iso standards
Experience
nc jindal public school
senior director, business process innovation
intuitive surgical
senior director of quality assurance and regulatory affairs
brainscope company inc.
r and d supplier quality manager
ev3 neurovascular
program manager, supplier quality engineering
ev3
engineer
k.c pharma
quality engineer, new product development
avail medical products
quality engineer
siegfried - expect more
* Project Completed: Concert Bone Cement, Medical Device Filling and Packaging (Aseptic filling of liquid, powder filling, packaging) * Worked on IOLs (Intra Ocular Lenses) * Design of Raw Material Inspection Specifications * Design of Labeling Process and Control * Medical device and drug manufacturing compliance with FDA regulations, ISO 9001, ISO13485 * Writing and executing test protocols for verification of equipment, processes and software * Auditing Suppliers * Hosting customer and Regulatory audits * Reviewing Engineering Validations and ensuring compliance * Writing and Reviewing SOPs, ensure Engineering and Production Documentation is adequate and compliant with FDA regulations
director of regulatory compliance
intuitive surgical
compliance manager
johnson & johnson
Education
university of houston, clear lake
nc jindal public school
villanova university
trinity law school
university of houston - clear lake
management
chatrapati sahuji maharaj kanpur university, kanpur
mechanical engineering
amit relia's Contact Information
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