Document Control Coordinator (EMEA Timezone : 3pm - 12am MYT - Remote)
Core
Managing document control systems to ensure regulatory compliance, product quality, and business operations in a regulated environment.
Role type
Document Control Specialist
Builds
Document control systems supporting Quality Management Systems (QMS)
Domain
Medical device/Pharma regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Document control processes, Change management (ECN/ECR), QMS knowledge, Regulatory standards (ISO 13485, GMP, FDA), Version control, Audit support, Record-keeping systems
Preferred skills
Engineering change management, Document management systems, Process improvement
Responsibilities
Implement and maintain document control processes aligned with QMS, Manage Change Notices in electronic document management and ERP systems, Coordinate with engineering, manufacturing, regulatory, and marketing teams, Maintain document accuracy, version control, and traceability, Support regulatory compliance requirements, Ensure documentation systems are audit-ready, Assist in internal and external audits, Identify opportunities for process improvements
Seniority
Individual Contributor