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.
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Key Responsibilities
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• Initiate, coordinate, and close change control records for product, process, and manufacturing changes.
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• Support design and development changes for drug -device combination products, including design control documentation.
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• Coordinate implementation of approved changes across manufacturing sites and ensure timely closure of change records.
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• Prepare and maintain post -market surveillance reports and annual risk management summaries.
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• Update and maintain risk management files in compliance with applicable regulations.
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• Support complaint investigations, root cause analysis, and documentation activities.
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• Collaborate with Engineering, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and external partners to drive project execution.
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• Maintain documentation within quality systems and ensure compliance with regulatory requirements.
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• Track project timelines, deliverables, and change implementation activities.
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  Required Qualifications
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  • Bachelor's degree in Engineering, Life Sciences, Quality, or a related discipline.
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  • 3–5 years of experience in medical device, combination product, pharmaceutical, or regulated manufacturing environments.
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  • Experience managing change controls, engineering changes, or product lifecycle activities.
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  • Knowledge of FDA, ISO 13485, cGMP, and medical device regulations.
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  • Experience with risk management activities, including FMEA and risk file maintenance.
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  • Familiarity with complaint investigations, CAPA, and quality systems processes.
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  • Strong organizational, project management, and documentation skills.
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  • Excellent communication and cross -functional collaboration abilities.
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    Preferred Qualifications
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    • Experience supporting drug -device combination products.
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    • Experience with Design Controls, Design History Files (DHF), and product development documentation.
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    • Hands -on experience with Veeva Vault, Agile PLM, Windchill, TrackWise, MasterControl, or similar systems.
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    • Knowledge of post -market surveillance and risk management reporting.
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      Key Skills
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      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
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      Interested candidates, Please share your resume to

      kavitha@dawarconsulting.com

      hr@dawarconsulting.cpm