Job Responsibilities:

• Lead the change control process for product changes, process changes, and documentation changes throughout their lifecycle.
• Evaluate change requests for completeness, accuracy, and compliance with regulatory requirements (e.g., US FDA, CE, ISO).
• Collaborate with cross-functional teams including Research & Development, Regulatory Affairs, Quality Assurance, Manufacturing, and Supply Chain to assess the impact of proposed changes.
• Facilitate change review meetings and ensure timely resolution of issues and decisions.
• Develop and maintain change control procedures, templates, and forms.
• Ensure that changes are properly documented, including rationale, risk assessment, validation requirements, and verification activities.
• Provide guidance and training to employees on change control procedures and best practices.
• Lead and manage multiple projects concurrently throughout their lifecycle from initiation to closure.
• Develop and execute validation protocols and reports for equipment, processes, and systems used in the manufacture and testing of medical devices including sterilization.
• Conduct qualification studies for equipment and software, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure that validation activities are conducted in accordance with FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), and other applicable regulatory requirements.
• Develop and maintain validation master plans, protocols, and validation summaries.
• Analyse validation data, prepare summary reports, and make recommendations for process improvements.