What are the responsibilities and job description for the Project Coordinator - Product Change Control position at Dawar Consulting, Inc.?
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.
- 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.
- 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
Salary : $90 - $100