Job Description
Job Description
Regulatory Affairs Coordinator - Hybrid role
Location: Irvine, CA 92618 (Hybrid – 2 days onsite/week)
Schedule: Monday–Friday, 8:00 AM–5:00 PM
This is a HYBRID role that requires on site attendance to Irving, CA. twice a week. Only candidates that live within a reasonable commute to Irving, CA. will be considered for this role.
Pay: $62.50/hr
Summary
Now hiring a Regulatory Affairs Coordinator 3 in Irvine, CA to support medical device regulatory operations and compliance activities. This Regulatory Affairs Coordinator role is a strong fit for someone who is highly detail-oriented, thrives in a fast-paced environment, and can manage multiple deadlines while keeping cross-functional teams aligned. You’ll support eIFU activities, maintain product and UDI data in PIM systems, and assist with distribution-related compliance workflows across the US, EU, and global markets. If you have strong regulatory fundamentals and can take ownership of documentation accuracy and timely execution, 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
- Support end-to-end distribution compliance activities, including certificate lifecycle management and distribution control releases (US/EU/ROW)
- Assist with compliance actions (including release controls and closure activities) aligned with regulatory and operational requirements
- Maintain proactive communication with internal stakeholders to support execution and compliance
- Help coordinate regulatory documentation updates tied to sustaining changes and integration efforts
- Support internal documentation readiness, tracking, and status reporting to ensure deadlines are met
Qualifications
- Bachelor’s degree in a related field or scientific discipline (required)
- Strong attention to detail with excellent organization, analytical thinking, and problem-solving skills (required)
- Ability to manage competing priorities and deliver accurate work under deadlines (required)
- Strong written and verbal communication skills; able to work cross-functionally (required)
- Knowledge of US FDA medical device regulations and EU MDR (Class II / IIa / IIb / III) (required)
- Experience supporting EU technical documentation, notified body change notifications, 510(k) support, and product lifecycle maintenance (preferred)
- Proficiency with Microsoft Office and document management systems (preferred)