Regulatory Affairs Coordinator
Job Description
Regulatory Affairs Coordinator (Medical Devices) – Hybrid
Location: Irvine, CA 92618 (Hybrid – 2 days onsite/week)
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Pay: $62.50/hr
Summary
Now hiring a Regulatory Affairs Coordinator in Irvine, CA to support fast-paced medical device regulatory operations. This Regulatory Affairs Coordinator role is hybrid (2 days onsite/week) and 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 escalate 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)
Job Requirements
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)