Document Control Coordinator (EMEA Timezone : 3pm - 12am MYT - Remote)

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

About the Role

We are seeking a detail-oriented and motivated Document Control Specialist to join our Document Control team. This role is critical in ensuring that our document control systems support regulatory compliance, product quality, and business operations. You will play a key role in managing change processes, maintaining document integrity, and supporting Quality Management Systems (QMS) across the organization globally. This is a great opportunity for someone who thrives in a regulated environment and enjoys working with cross-functional teams.

Key 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.

About You

• Experience in document control, quality assurance, or regulated environments (medical device/pharma preferred).
• Familiarity with QMS and regulatory standards (e.g., ISO 13485, GMP, FDA requirements) is highly desirable.
• Knowledge of engineering change management processes (ECN/ECR).
• Strong attention to detail and organizational skills.
• Ability to manage multiple tasks and work independently.
• Strong communication skills with the ability to collaborate across teams.
• Comfortable working with document management systems and digital tools.
• Vocational training or equivalent experience in a relevant field.

What You’ll Bring

• A proactive and solution-focused mindset.
• Ability to act as a subject matter resource for document control processes.
• Strong commitment to quality, compliance, and accuracy.
• Continuous improvement mindset.

Why Join Us?

Be part of a collaborative and supportive Quality Assurance team. Work in a role that directly impacts product quality and compliance. Opportunity to contribute to global quality systems and processes. Career growth and professional development opportunities.

Resmed (NYSE:RMD, ASX: RMD) creates life-changing health technologies that people love. We’re relentlessly committed to pioneering innovative technology to empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices and intelligent software make home healthcare more personalized, accessible and effective. Ultimately, Resmed envisions a world where every person can achieve their full potential through better sleep and breathing, with care delivered in their own home. Learn more about how we’re redefining sleep health at Resmed.com and follow @Resmed.

We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, we commit to respond to every applicant.