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.

• 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.
  

• Bachelors degree in Engineering Life Sciences Quality or a related discipline.
  
• 35 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.
  

• 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.
  

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