Regulatory Operations Analyst
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Regulatory professional working in medical devices industry. Gaining expertise in Medical Device Registration, Renewal, Update and Providing regulatory intelligence. An organized and creative professional with proven technical skills and a desire to learn more.
Reubens Hospitech Pvt.Ltd - Mar 2021 to Present
Updating regulatory documents, simultaneously conducting internal audits on regular basis.
Implementing compliance related to IEC 60601-1 for Basic Safety and Essential Performance of Medical Device.
Documented technical file for ISO 80601-2-13, ISO 15001 standards of Anesthesia Workstation. Product registrations with supervision, evaluate, prepare and submit medical registration applications to BIS.
MGM College of Engineering Kamothe Biomedical Engineering Year 2019 CGPI 8
