Quality, Regulatory & Compliance Officer, Korea.

Empowering careers at ARJO

At Arjo, we know what moves us. We go above and beyond for people facing mobility challenges. We take every opportunity to work and grow as one team and take pride in sharing our knowledge and experience. Does that sound like something that moves you too?

This could be your opportunity to begin a challenging and rewarding career in a healthcare company that empowers movement for people with mobility challenges.

We are seeking a proactive and detail-oriented Quality Regulatory & Compliance (QRC) Officer to join our Korea team. This role is responsible for supporting quality, regulatory and compliance activities to ensure our products, systems and processes meet local regulatory requirements and international quality standards. 

This is an excellent opportunity for a quality professional who enjoys working across multiple functions, driving continuous improvement, and contributing to the delivery of safe, compliant healthcare products. 

Key Responsibilities

As the QRC Officer, you will:

Quality Management & Compliance

•    Support the implementation and maintenance of the Integrated Management System (IMS).
•    Assist in maintaining compliance with ISO 9001, ISO 14001 ISO 13485  and ISO 45001 requirements.
•    Conduct and support internal audits and assist with external audit preparation.
•    Support quality, environmental, health and safety compliance activities. 

Regulatory Affairs & Product Registration

•    Prepare and maintain regulatory documentation and import licence requirements.
•    Support new product registrations and certification activities.
•    Liaise with regulatory authorities, consultants and certification bodies.
•    Ensure products remain compliant with Korean and applicable international regulations.
•    Provide guidance and training to internal teams, importers and distributors on regulatory requirements.

Complaints & Post-Market Surveillance
•    Manage complaint handling activities in accordance with established procedures.
•    Ensure accurate documentation and timely reporting of customer complaints.
•    Support investigations and communication with relevant stakeholders.
•    Assist with adverse event and incident reporting activities. 

Field Actions & Regional Support

•    Assist with field action and recall activities.
•    Support regional quality and compliance initiatives and projects.
•    Participate in cross-country audits and quality improvement activities.
•    Deliver quality and compliance training when required. 

About You

To be successful in this role, you will have:

•    2-3 years' experience in a Quality Assurance, Regulatory Affairs or Compliance environment.
•    Knowledge of ISO 9001 and experience supporting or conducting internal audits.
•    Understanding of Korean regulatory requirements and quality management systems.
•    Strong organisational and time management skills.
•    Excellent communication and stakeholder management abilities.
•    High attention to detail and a commitment to quality standards.
•    Intermediate Microsoft Office skills including Excel, Word, PowerPoint and Outlook. 

Desirable

•    Internal Auditor qualifications.
•    Experience with ISO 14001 and/or ISO 45001 systems.
•    Qualification in Quality Management, Regulatory Affairs, Occupational Health & Safety or a related discipline.
•    Advanced Microsoft Office or SharePoint skills. 

Why Join Us?

•    Be part of a global healthcare organisation committed to improving patient outcomes.
•    Work within a collaborative and supportive team environment.
•    Gain exposure to regional quality and regulatory activities.
•    Participate in continuous improvement and professional development opportunities.
•    Make a meaningful impact on quality, compliance and patient safety. 

If you are passionate about quality, compliance and continuous improvement and are looking to grow your career within a global organisation, we'd love to hear from you.

Apply now and help us make a difference.

About Arjo

At Arjo, we believe that empowering movement within healthcare environments is essential to quality care. Our products and solutions are designed to promote a safe and dignified experience through patient handling, medical beds, personal hygiene, disinfection, diagnostics, and the prevention of pressure injuries and venous thromboembolism. With over 6500 people worldwide and 65 years caring for patients and healthcare professionals, we are committed to driving healthier outcomes for people facing mobility challenges.

For more information about Arjo visit www.arjo.com