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)

Meet Your Recruiter

Holly Romain


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View email address on click.appcast.io


About Irvine, CA


Take the next step in your career journey in the vibrant city of Irvine, California! Nestled in the heart of Orange County, this thriving community offers unparalleled growth opportunities and an unbeatable quality of life. With its close proximity to stunning beaches, world-class shopping at South Coast Plaza, a bustling culinary scene featuring diverse cuisine options, and cultural attractions like the Irvine Museum and Irvine Barclay Theatre, Irvine has something for everyone. Whether you're into outdoor activities in Irvine Regional Park or catching a game at the Angel Stadium of Anaheim or the Honda Center, this region has it all. Explore our job listings today and discover why Irvine is the perfect place to advance your career!


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