Job Description

Job Title:

Change Control Specialist

Overview:

This role is responsible for overseeing and driving compliant change control processes across product specifications, manufacturing operations, and documentation. The specialist will manage change control boards, electronic quality systems, and cross-functional collaboration to ensure traceable, risk-based decisions that meet regulatory requirements.

Key Responsibilities:

• Change Control Management
• Lead the end-to-end change control process: initiation, impact assessment, approval, implementation, and documentation.
• Coordinate Change Control Board (CCB) meetings and ensure timely, well-documented decision-making.
• Work cross-functionally with Quality, Regulatory, R&D, and Manufacturing to align changes with compliance requirements.
• Product and Process Change Oversight
• Evaluate change proposals for compliance with FDA QSR (21 CFR Part 820), ISO 13485, and other applicable regulations.
• Facilitate risk assessments and root cause analysis as part of change evaluations.
• Support implementation of product/process changes and verify effectiveness post-change.
• Document Control & eQMS Administration
• Manage document control operations within the electronic QMS, ensuring controlled documents are up to date and audit-ready.
• Oversee version control, SOP workflows, technical file updates, and documentation alignment with quality standards.
• Administer eQMS access rights, authorizations, and user training.
• Training & Stakeholder Support
• Deliver training and guidance on change control procedures, risk documentation, and document lifecycle best practices.
• Host workshops and refresher sessions to ensure consistent understanding of quality system expectations.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• 3+ years of change control experience in a regulated industry (medical device or pharma preferred).
• Proficient in FDA QSR, ISO 13485, and cGMP standards.
• Hands-on experience with eQMS platforms and document control systems.
• Strong organizational, communication, and project coordination skills.

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