Coordinator 3, Regulatory Affairs (Hybrid)

Coordinator 3, Regulatory Affairs

Location: Irvine, CA (Hybrid: 2 days/week onsite — Local candidates only)

Contract Duration: 6 months (Possibility of extension)

Pay Rate: $61.00/hour W2

Schedule: Monday – Friday, 8:00 AM – 5:00 PM

Position Overview

In this role, you will play a hands-on part in systems integration activities, eIFU management, product distribution controls, and technical filing documentation across US and EU jurisdictions.

This is a fast-paced environment supporting a major integration initiative. We are looking for candidates who take high ownership of their deliverables, possess deep familiarity with medical device classifications, and excel at cross-functional communication.

Key Responsibilities

• eIFU & Web Platform Management: Handle electronic Instructions for Use (eIFU) activities, including metadata management, required form completion, and uploading content to online portals.
• Product Information Management (PIM): Input key attributes into global databases (UDI, EUDAMED, and international regulatory repositories).
• End-to-End Distribution Controls: Execute distribution-related compliance actions across sustaining projects and integration efforts. Manage certificate lifecycles, execute hard-stop holds, coordinate distribution control releases for US/EU/ROW, and complete closure activities.
• Technical Filings & Modifications: Assess the regulatory impact of device modifications. Author robust non-filing justifications ("Letters to File") for US FDA and update EU Technical Documentation accordingly.
• Global Regulatory Support: Support 510(k) compilations, Notified Body change notifications, and ongoing product lifecycle maintenance in collaboration with global cross-functional teams.

Required Qualifications & Experience

• Education: Completed Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Biomedical Engineering, Life Sciences).
• Experience: Minimum 5 years of hands-on experience handling EU regulatory deliverables for medical devices. Please list experience in US and EU RA change control management.
• Regulatory Expertise: Deep working knowledge of US FDA Class II and EU MDR Class IIa/IIb/III regulations.
• Technical Authoring: Direct experience authoring EU Technical Documentation, supporting Notified Body notifications, compiling 510(k) submissions, and maintaining product lifecycles.
• System Proficiency: Working experience with electronic Document Management Systems (eDMS), PIM tools, and MS Office.
• Location: Must be strictly local to Irvine, CA (or immediate surrounding area) to accommodate the 2-day/week hybrid schedule from Day 1.

Preferred Qualifications

• Experience navigating integration or legacy system migration activities within major medical device manufacturers.
• Familiarity with global (ROW) regulatory requirements beyond US/EU.
• Formal regulatory training, certifications (e.g., RAC), or specialized trade association coursework.