Document Control Coordinator, EMEA Timezone

🕒 2 days ago

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ResMed

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1989

⚕️ Healthcare Insurance

☁️ SaaS

💰 Post-IPO Debt on 2019-07

Healthcare Insurance • SaaS

ResMed is a global leader in sleep technology and respiratory care, focused on improving out-of-hospital care to enhance the health and quality of life for individuals with chronic diseases. With over 30 years of innovation, ResMed develops life-changing technology and provides software platforms that support medical professionals and caregivers in helping patients manage their health from home or in preferred care settings. The company is committed to diversity and inclusion, supporting a wide range of professionals in building meaningful careers, and shaping the future of connected health care with the goal of impacting 250 million lives worldwide.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• Career growth and professional development opportunities • Opportunity to contribute to global quality systems and processes