Project Coordinator - Product Change Control

Our client, a leading biotechnology company, is seeking a Project Coordinator to support commercial combination products throughout the product lifecycle. This role will be responsible for managing change control activities, maintaining risk management documentation, coordinating post -market surveillance reporting, and partnering with cross -functional teams to ensure product quality and supply continuity.

Key Responsibilities

• Initiate, coordinate, and close change control records for product, process, and manufacturing changes.
  
• Support design and development changes for drug -device combination products, including design control documentation.
  
• Coordinate implementation of approved changes across manufacturing sites and ensure timely closure of change records.
  
• Prepare and maintain post -market surveillance reports and annual risk management summaries.
  
• Update and maintain risk management files in compliance with applicable regulations.
  
• Support complaint investigations, root cause analysis, and documentation activities.
  
• Collaborate with Engineering, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and external partners to drive project execution.
  
• Maintain documentation within quality systems and ensure compliance with regulatory requirements.
  
• Track project timelines, deliverables, and change implementation activities.
  

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or a related discipline.
  
• 3–5 years of experience in medical device, combination product, pharmaceutical, or regulated manufacturing environments.
  
• Experience managing change controls, engineering changes, or product lifecycle activities.
  
• Knowledge of FDA, ISO 13485, cGMP, and medical device regulations.
  
• Experience with risk management activities, including FMEA and risk file maintenance.
  
• Familiarity with complaint investigations, CAPA, and quality systems processes.
  
• Strong organizational, project management, and documentation skills.
  
• Excellent communication and cross -functional collaboration abilities.
  

Preferred Qualifications

• Experience supporting drug -device combination products.
  
• Experience with Design Controls, Design History Files (DHF), and product development documentation.
  
• Hands -on experience with Veeva Vault, Agile PLM, Windchill, TrackWise, MasterControl, or similar systems.
  
• Knowledge of post -market surveillance and risk management reporting.
  

Key Skills

Change Control | Design Controls | Risk Management | ISO 13485 | FDA 21 CFR Part 820 | cGMP | CAPA | Complaint Investigation | DHF | FMEA | Post -Market Surveillance | Veeva Vault | Project Management | Cross -Functional Collaboration | Combination Products | Medical Devices | Pharmaceutical Operations