Rajpal Jagtap
Regulatory Operations Analyst
Hire this person
Send a job offer directly to this candidate
About
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.
Experience
REGULATORY AFFAIRS ASSOCIATE
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.
Education
MGM College of Engineering Kamothe Biomedical Engineering Year 2019 CGPI 8