Assistant Manager Regulatory Affairs (RA)

Regulatory Strategy & Compliance US, FDA, MDR Documentation & Submissions Regulatory Monitoring/ Reporting, Submission of UDI to GUDID/EUDAMED Regulatory Audits and Inspections CAPAs, NCs closure Navigating regulatory requirement for CDSCO, US FDA,°BE/BTech- Mech. min. 5 years of exp. in regulatory affairs with medical device industry, strong understanding of U.S. FDA and European regulatory requirements, EU MDR 2017, ISO 13485, RAC, CDSCO.°