Global Document Control & Compliance Specialist

ResMed Inc; Johor Bahru; Remote; MYR 60,000 - 90,000; Full time

Job summary

ResMed in Malaysia is seeking a detail-oriented Document Control Specialist to join our global QA/Regulatory team. You will manage document control processes, maintain version control, and support QMS across locations, ensuring audit readiness.

You will collaborate with engineering, manufacturing, regulatory, and marketing to document changes in the ERP (Oracle) and DMS, drive continuous improvement, and uphold integrity of records.

Qualifications

• Experience in document control, quality assurance, or regulated environments (medical device/pharma preferred).
• Familiarity with QMS and regulatory standards (ISO 13485, GMP, FDA requirements).
• Knowledge of engineering change management processes (ECN/ECR).

Responsibilities

• Implement and maintain document control processes aligned with Quality Management Systems across the organization.
• Manage Change Notices, ensuring timely and accurate documentation of product and process changes in the electronic document management system and the ERP system (Oracle).
• Coordinate with engineering, manufacturing, regulatory, and marketing teams and other areas as needed to ensure changes are properly documented and communicated.
• Maintain document accuracy, version control, and traceability across systems.
• Support regulatory compliance requirements.
• Ensure documentation systems are audit-ready and compliant with internal policies and external regulations.
• Assist in internal and external audits, including preparation and follow-up activities.
• Identify opportunities for process improvements and support continuous improvement initiatives.
• Maintain secure and accurate record-keeping systems.

Skills

Document control

Quality assurance

Regulated environments

Attention to detail

Cross-functional collaboration

Education

Vocational training or equivalent

Tools

Oracle ERP

Document management system

Job description

ResMed in Malaysia is seeking a detail-oriented Document Control Specialist to join our global QA/Regulatory team. You will manage document control processes, maintain version control, and support QMS across locations, ensuring audit readiness.

You will collaborate with engineering, manufacturing, regulatory, and marketing to document changes in the ERP (Oracle) and DMS, drive continuous improvement, and uphold integrity of records.