Regulatory Affairs Coordinator

Join Kelly FSP as a Regulatory Affairs Coordinator on site with our Medical Device client in Irvine, CA! Hybrid Position Tuesday and Thursday in office. Job DescriptionPurposeProvide support to the Regulatory Affairs department to manage Coordination of training for all Regulatory Affairs (RA) staff globally; Coordinate records maintenance; manage Purchase Orders under budget constraints; lead all administrative duties as requested.ResponsibilitiesResponsible for ensuring personal compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental complianceProvides administrative support to the RA department as directed.Organizes and maintains regulatory compliance documents and databases.Maintains database index of regulatory information regarding company products.Organizes, maintains and archives electronic and hard copies of submission records, certificates and other regulatory documentation.Assist during regulatory and supplier/distributor audits. and maintains audit files.Compiles compliance information, provides periodic updates on training requirements and records maintenance to department staffprovides routine and non-routine regulatory reports as requested and keeps regulatory listings current.Participates in compliance activities and responds to moderately complex compliance queries.Prepares and enters Purchase Orders (for FDA/Notified body fees, check request, Annual Fees, .. ). Works with Regulatory Affairs, Manufacturing, R&D, and other areas to obtain copies of documents for registration.Prepares and submits Certificate of Finished Goods (CFG) from FDA CSCATS porthole. Maintain in SharePoint.Ordering office supplies and helping with new hire onboardings.Perform other duties as assigned.Facilitates and maintains department meeting minutes.QualificationsBachelor's degree is preferred2 years of related experience and/or training in a regulated environment (Regulatory, Clinical or Legal)Medical Device Regulatory Affairs experience is highly desired.Strong Attention to detailsBeing organizedQuality and process improvement oriented,Must be proficient with MS Office applicationsExcellent communication skills (verbal and written)Strong organizational skillsProject management skillsProblem solving skillsNotary is a plus but not requiredMust be on Irvine campus 2 days a week (Tuesday and Thursday)

Created: 2025-01-25