Regulatory Affairs Coordinator

Regulatory Affairs Coordinator (Medical Devices) Location: Irvine, CA 92618 (Hybrid – 2 days onsite/week) Schedule: Monday–Friday, 8:00 AM–5:00 PM Pay: $62.50/hr Now hiring a Regulatory Affairs Coordinator in Irvine, CA to support fast‑paced medical device regulatory operations. This role focuses on execution‑heavy regulatory support: eIFU coordination, product data/metadata maintenance, documentation updates, and cross‑functional follow‑up to keep compliance deliverables moving on time. If you are detail‑oriented, organized, and comfortable managing multiple deadlines in a regulated environment, apply today. Responsibilities Support eIFU (electronic Instructions for Use) activities, including metadata management, required forms, and timely uploads. Perform Product Information Management (PIM) entries, including UDI, EUDAMED, and other country UDI database attributes. Execute and support distribution‑related compliance activities, including certificate lifecycle management and distribution control releases (US/EU/ROW). Support compliance actions such as holds, release controls, and closure activities aligned with regulatory and operational requirements. Maintain proactive communication with internal stakeholders; identify issues early and elevate as needed. Support regulatory documentation updates for sustaining projects and integration activities. Assist with letters‑to‑file and technical documentation updates as assigned. Qualifications Bachelor’s degree in a related field or scientific discipline (required). Strong attention to detail with excellent organizational, analytical, and problem‑solving skills (required). Ability to manage competing priorities and meet deadlines in a fast‑paced environment (required). Working knowledge of US FDA and EU MDR medical device regulations (Class II / IIa / IIb / III) (required). Experience supporting EU technical documentation, notified body change notifications, and/or 510(k) activities (preferred). Proficiency with Microsoft Office and document management systems (preferred). #J-18808-Ljbffr