Regulatory Affairs Specialist

Planet Group
Irvine, CA


HM's Top Needs:
1. EU Labeling Requirements
2. Global labeling requirements, 21 CFR 801, EU MDR Regulation, ISO15223, ISO20417
3. Project Management and Change Management skills

Education Required: MS in Science, engineering or regulatory.

Years’ Experience Required: 5-9 years

Will the contractor be working 40 hours a week? If not, weekly estimate? 40

Work Location: Irvine

Do they need to be local to any MDT office and if so where? Irvine or near by

Does this person need to be on site? If so, full time or part time? Onsite - minimum 4 days

  • Accountable for the regulatory labeling deliverables for various project types (i.e. submission, new product development, sustaining, launches, manufacturing transfer, etc.)
  • Manage and support assessment and template creation for new and changing requirements.
  • Prepare technical product documentation including plans, reports, and engineering change orders, etc.
  • Maintain artwork content for all labeling types including Instructions for Use documents, product labels, Patient labeling, electronic labeling, label stocks, and carton in compliance with applicable regulations, standards, company policies, processes as well as internal labeling requirements.
  • Estimates labeling projects level of effort, resource requirements and works with stakeholders to understand the scope of effort and tasks necessary to complete the project.
  • Collaborate with multi-functional team (R&D engineering, marketing, manufacturing, operations, regulatory, legal, quality, clinical, medical safety) to facilitate completion of labeling artwork projects
  • Tracks labeling project schedules, identify risks/issues, determine resolution and communicates project status or escalations by participating in departmental and project team meetings.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Manage labeling, UDI and barcode grading processes and systems as related to product labeling
  • Other duties as assigned or required

Posted 2025-11-15

Recommended Jobs

Senior Staff/Principal Software Engineer

Zoox
Foster, CA

Maestro is the core system responsible for efficiently managing Zoox's automated fleet operations. It assigns various jobs to autonomous vehicles, including rideshare trips, charging, cleaning, and o…

View Details
Posted 2026-01-07

Software Engineer, Backend - Sora

Openai
San Francisco, CA

About the Team The Sora team is pioneering multimodal capabilities for OpenAI’s foundation models. We’re a hybrid research and product team focused on integrating multimodal functionalities into our…

View Details
Posted 2025-11-28

Software Engineer

Figure
San Jose, CA

Figure is an AI Robotics company developing a general purpose humanoid. Our humanoid robot, Figure 02, is designed for commercial tasks and the home. We are based in San Jose, CA and require 5 days/w…

View Details
Posted 2025-11-25

Principal Product Manager, Platform

Harness
Mountain View, CA

Harness is a high-growth company that is disrupting the software delivery market. Our mission is to enable the 30 million software developers in the world to deliver code to their users reliably, e…

View Details
Posted 2025-11-28

Lab Technician III - Chemistry (Harbor 1 - QC) - Days

Robinson Pharma
Santa Ana, CA

The Quality Control Lab Technician III – Chemistry ensures company standards are met for all functions as they pertain to the QC Laboratory. Overtime maybe required to meet business needs. Respo…

View Details
Posted 2025-12-10

Information Technology Manager I - Telework Hybrid

Department of Motor Vehicles
Sacramento County, CA

Job Description and Duties This position is located at the DMV Headquarters in Sacramento. This position is located at the Sacramento DMV Headquarters. Your role is pivotal in ensuring the seam…

View Details
Posted 2025-12-31

Controller POST NUMBER: 406504

Los Angeles, CA

We are seeking an experienced Real Estate Controller to oversee the financial operations of our real estate business. The successful candidate will be responsible for managing the accounting and fina…

View Details
Posted 2025-12-16

Regional Sales Manager- West

Accordance Search Group
Los Angeles, CA

Regional Sales Manager-West Responsibilities: Hires, develops, and oversees the work of the regional sales team Develops and implements a sales strategy, processes Works with stakeholders …

View Details
Posted 2026-01-09

Pastry Chef de Partie

The French Laundry
Yountville, CA

Chef Thomas Keller’s Yountville destination, The French Laundry, is looking for individuals who are enthusiastic about food, beverage and hospitality to join the culinary brigade as a Pastry Chef de …

View Details
Posted 2026-01-01