Regulatory Affairs Coordinator

Regulatory Affairs CoordinatorExperience in regulatory affairs or a similar administrative role coming from a medical device/biotech/pharmaceutical company. Strong organizational and time management skills. Excellent written and verbal communication skills. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint). Bachelor's Degree.A large medical device company in Irvine, CA is looking for a Regulatory Affairs Coordinator to provide administrative support to ensure operation of regulatory activities and compliance with industry standards. Their responsibilities will include but are not limited to:Supporting the regulatory department as a training coordinator and a records coordinatorOpen / understand purchase orders and timelinesAssist with the documentation of technical FDA documentsPrepare, review, and run team meetingsTrack and monitor regulatory submissions and approvals, ensuring timely follow-up and documentation.Liaise with internal departments and external partners to gather necessary information for regulatory submissions.Prepare and distribute regulatory reports, summaries, and presentations.Assist in the preparation of responses to regulatory inquiries and audits.